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Able Groupe Inc

21 recall records on file.

2021

20 records

Class ITerminatedRecall F-0907-2021

Product description

HiPP Comfort Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes.
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0908-2021

Product description

HiPP AR Germany Anti-Reflux Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0909-2021

Product description

HiPP Dutch Stage 1 Combiotic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0910-2021

Product description

HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0911-2021

Product description

HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0912-2021

Product description

HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0913-2021

Product description

HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0914-2021

Product description

HiPP German Stage 1 Combiotic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0915-2021

Product description

HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0916-2021

Product description

Holle Bio Stage 1 Organic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0917-2021

Product description

Holle Bio Stage PRE Organic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0918-2021

Product description

Holle Bio Stage 2 Organic Follow-On Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0919-2021

Product description

Holle Goat Stage 1 Organic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0920-2021

Product description

Holle Goat Stage 2 Organic Follow-On Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0921-2021

Product description

Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0922-2021

Product description

Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0923-2021

Product description

Lebenswert Folgemilch Stage 3 Organic Toddler Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class ITerminatedRecall F-0924-2021

Product description

HiPP UK Stage 1 Combiotic First Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0925-2021

Product description

HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021
Class IITerminatedRecall F-0926-2021

Product description

Kendamil Organic Stage 1 First Infant Milk Formula

Reason for recall

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

View full record
Event ID
88432
Code info
All codes
Product quantity
76,000 units total
Distribution pattern
All sales are direct from firm website - littlebundle.com
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Food
Recalling firm location
1486 Kleppe Ln, N/A, Sparks, NV, United States
Recall initiation date
08/08/2021
Center classification date
09/01/2021
Termination date
09/08/2021