Recalls / Class III
Class IIID-0974-2016
Product
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- Affected lot / code info
- Lot#: 47312-1, Exp 01/2018
Why it was recalled
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Recalling firm
- Firm
- Aidarex Pharmaceuticals LLC
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 595 N Smith Ave Ste B, N/A, Corona, California 92880-6920
Distribution
- Quantity
- 10
- Distribution pattern
- IN, GA
Timeline
- Recall initiated
- 2016-06-01
- FDA classified
- 2016-06-07
- Posted by FDA
- 2016-06-15
- Terminated
- 2016-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0974-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.