Multi-event June 2020 FDA Recall Drug by Teva Pharmaceuticals Usa

This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on June 2, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed throughout the United States, including Puerto Rico. and the recall is currently terminated.

Reported Recall Events

D-1332-2020 TERMINATED D-1331-2020 TERMINATED

Recall Number: D-1332-2020

Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Initiated
06-02-2020
Reported
07-01-2020
Quantity
a) 15,329 bottles and b) 137 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-12-2024
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

Batch or Lot Expiration Information

Lot# a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021

Recall Number: D-1331-2020

Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Initiated
06-02-2020
Reported
07-01-2020
Quantity
a) 92,793 bottles and b) 4,824 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-12-2024
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

Batch or Lot Expiration Information

Lot# a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M,, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021