Dr. Reddy's Laboratories, Inc.: Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS D

Is my product affected?

Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville

• Brand FAMOTIDINE

Check against the official notice below — it lists the full affected range.

What happened

Dr. Reddy's Laboratories, Inc. is recalling CVS Pharmacy Acid Controller famotidine tablets, 10 mg, in 30-count bottles distributed nationwide. The recall affects 569,376 bottles due to failed impurities and degradation specifications. During routine stability testing at 24 months, a batch tested positive for an out-of-specification level of impurity 8 (a related substance). The affected products were distributed under NDC 55111-118-30 by CVS Pharmacy, Inc., and specific lot numbers and expiration dates are identified in the recall notice.

Consumers who have purchased affected lots should check their bottle's lot number and expiration date against those listed in the recall. The source document does not specify a remedy or recommended action for consumers with recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.

Details from the source

Reason for recall: Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval. Distribution: Nationwide Quantity: 569376 bottles Lot/code info: Lot #: a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp 3/18; b) 79C408885B, 79C408886A, Exp 10/17; 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B, Exp 01/18; 79C502317A, Exp 3/18; 79C504087B, 79C504088A, Exp 5/18; 79C505926A, Exp 7/18.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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