CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Reported: June 15, 2016 Initiated: June 1, 2016 #D-0974-2016
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.
Details
- Recalling Firm
- Aidarex Pharmaceuticals LLC
- Units Affected
- 10
- Distribution
- IN, GA
- Location
- Corona, CA
Frequently Asked Questions
What product was recalled? ▼
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01. Recalled by Aidarex Pharmaceuticals LLC. Units affected: 10.
Why was this product recalled? ▼
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2016. Severity: Low. Recall number: D-0974-2016.
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