Why it was recalled
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Product description
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Lot numbers, UPCs & expiration codes
Lot#: 47312-1, Exp 01/2018
Where it was sold
IN, GA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0974-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 1, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 10
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidarex Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0974-2016, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74316
- Address
- 595 N Smith Ave Ste B
- Code information
- Lot#: 47312-1, Exp 01/2018
- Postal code
- 92880-6920
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0974-2016
- Classification
- Class III
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Product quantity
- 10
- Termination date
- Oct 14, 2016
- Reason for recall
- CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- Distribution pattern
- IN, GA
- Recall initiation date
- Jun 1, 2016
- Initial firm notification
- FAX
- Center classification date
- Jun 7, 2016