Multi-event March 2014 FDA Recall Drug by Teva Pharmaceuticals Usa

This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on March 24, 2014 for the product Drug. The FDA reported the reason for recall as cgmp deviations; laboratory testing was not followed in accordance with gmp requirements. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1294-2014 TERMINATED D1292-2014 TERMINATED D-1293-2014 TERMINATED D-1295-2014 TERMINATED

Recall Number: D-1294-2014

Reason for Recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Initiated
03-24-2014
Reported
05-21-2014
Quantity
7,694 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67811
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2014
Product Description About Product Description
Full technical description of the product.
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01

Batch or Lot Expiration Information

Lot# TE32134, Exp. 02/15

Recall Number: D1292-2014

Reason for Recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Initiated
03-24-2014
Reported
05-21-2014
Quantity
22820 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67811
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2014
Product Description About Product Description
Full technical description of the product.
METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01

Batch or Lot Expiration Information

Lot# TE36053A,TE36063A, Exp. 06/16

Recall Number: D-1293-2014

Reason for Recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Initiated
03-24-2014
Reported
05-21-2014
Quantity
2532 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67811
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2014
Product Description About Product Description
Full technical description of the product.
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05

Batch or Lot Expiration Information

Lot# TE36018, Exp. 06/15

Recall Number: D-1295-2014

Reason for Recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Initiated
03-24-2014
Reported
05-21-2014
Quantity
5812 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67811
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2014
Product Description About Product Description
Full technical description of the product.
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Batch or Lot Expiration Information

Lot# TE38139, Exp. 08/16, TE39022, Exp. 09/16