CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

FDA recall notice · announced June 15, 2016 · Aidarex Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: IN, GA
Lot/code information: Lot#: 47312-1, Exp 01/2018
Quantity: 10
Status: Terminated
Products in this recall event:
- CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01 (D-0974-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.