D-1661-2012 Class II Terminated
FDA drug recall D-1661-2012 was initiated by Apotex Corp. on Jun 14, 2007 and is designated Class II. Reason for recall: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. The recall status is terminated (terminated Aug 28, 2012). Affected quantity: 3063.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2012
- Initiation Date
- Jun 14, 2007
- Termination Date
- Aug 28, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3063
Product Description
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9
Reason for Recall
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Distribution Pattern
Nationwide.
Code Information
Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1661-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026