Why it was recalled
cGMP Deviations: deviations leading to potential cross-contamination.
Product description
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Lot numbers, UPCs & expiration codes
Lot#: 023011 Exp 8/31/2022
Where it was sold
USA Nationwide
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-1354-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 5040 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sc Inc
Original FDA data
Every field from FDA enforcement report D-1354-2022, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 90703
- Address
- 4500 12th Street Ext
- Code information
- Lot#: 023011 Exp 8/31/2022
- Postal code
- 29172-3025
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1354-2022
- Classification
- Class II
- Recalling firm
- Nephron Sc Inc
- Product quantity
- 5040 vials
- Termination date
- Sep 24, 2024
- Reason for recall
- cGMP Deviations: deviations leading to potential cross-contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2022