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ULTRAtab Laboratories, Inc.

9 recall records on file.

2022

9 records

Class IITerminatedRecall F-0721-2022

Product description

Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M943 M943L Bulk Lots: 16K038, 18B075
Product quantity
4,250,842 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0722-2022

Product description

Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046
Product quantity
26,682,419 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0723-2022

Product description

Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

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Event ID
89512
Code info
Product Codes: M960L Bulk Lots: 19E021, 19E022
Product quantity
1,904,760 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0724-2022

Product description

Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M961L Bulk Lots: 19E030, 19E031
Product quantity
1,606,966 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0725-2022

Product description

Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M962L Bulk Lots: 19E032, 19E033
Product quantity
1,393,353 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0726-2022

Product description

Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M975 Bulk Lots: 19E058
Product quantity
955,928 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0727-2022

Product description

Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M976 Bulk Lots: 19B050, 19F063
Product quantity
5,853,539 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0728-2022

Product description

Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023
Product quantity
1,478,344 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022
Class IITerminatedRecall F-0729-2022

Product description

MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

View full record
Event ID
89512
Code info
Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050
Product quantity
42,352,387 tablets
Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
50 Toc Dr, N/A, Highland, NY, United States
Recall initiation date
10/06/2021
Center classification date
02/09/2022
Termination date
09/01/2022