D-1703-2012 Class III Terminated
FDA drug recall D-1703-2012 was initiated by Mylan Pharmaceuticals Inc. on Jun 28, 2012 and is designated Class III. Reason for recall: Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing. The recall status is terminated (terminated Mar 29, 2013). Affected quantity: 31,867 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 10, 2012
- Initiation Date
- Jun 28, 2012
- Termination Date
- Mar 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,867 Bottles
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.
Distribution pattern
Nationwide and PR
Code information
Lot: 3018952, Exp 08/12
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1703-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026