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

Recall date

October 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0009-2018

FDA classification

Class III

Brand / firm

Dr. Reddy's Laboratories, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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, AR 72716, Made in India