D-0974-2016 Class III Terminated
FDA drug recall D-0974-2016 was initiated by Aidarex Pharmaceuticals LLC on June 1, 2016 and is designated Class III. Reason for recall: CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API. The recall status is terminated (terminated October 14, 2016). Affected quantity: 10.
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- June 1, 2016
- Termination Date
- October 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Reason for Recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Distribution Pattern
IN, GA
Code Information
Lot#: 47312-1, Exp 01/2018