D-0769-2016 Class III Terminated
FDA drug recall D-0769-2016 was initiated by Golden State Medical Supply Inc. on Jan 27, 2016 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Jun 28, 2016). Affected quantity: 172 100-count packages (17,200 tablets).
Recall details
- Product Type
- Drugs
- Report Date
- Mar 16, 2016
- Initiation Date
- Jan 27, 2016
- Termination Date
- Jun 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172 100-count packages (17,200 tablets)
Product description
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
Reason for recall
Failed Impurities/Degradation Specifications
Distribution pattern
Nationwide
Code information
Lot #GS009075; Exp. 09/17 Lot #GS009763; Exp. 09/17 Lot #GS010178; Exp. 10/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0769-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026