PlainRecalls
FDA Drug Low Class III Terminated

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

Reported: October 10, 2012 Initiated: June 28, 2012 #D-1703-2012

Product Description

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

Reason for Recall

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Details

Units Affected
31,867 Bottles
Distribution
Nationwide and PR
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 31,867 Bottles.
Why was this product recalled?
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 10, 2012. Severity: Low. Recall number: D-1703-2012.