Famotidine Tablets USP recall: Impurity Out of Spec
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Why was Famotidine Tablets USP recalled?
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 3018952, Exp 08/12
- Product
- Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 31,867 Bottles
- Distribution
- Nationwide and PR
- Recall date
- October 10, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)