Why it was recalled
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Product description
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Lot numbers, UPCs & expiration codes
Lot # XI002A6, XI003A6, Exp 12/17; XI004G6, XI005G6, Exp 6/18; XI007H6, Exp 7/18; XI00816, XI00916, XI01016, XI01116, Exp 8/18; XI012J6, XI013J6, Exp 9/18; XI015K6, Exp 10/18; XI016L6, Exp 11/18; XL018A7, XI019A7, Exp 12/18; XI020B7, XI021B7, Exp 1/19; XI022C7, XI023C7, Exp 2/19; XI025D7, Exp 3/19.
Where it was sold
Distributed throughout the United States
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-1124-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 15, 2017
- FDA report date
- Sep 6, 2017
- Quantity
- 637,810 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amphastar Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1124-2017, exactly as published.
Show all FDA fields
- City
- Rancho Cucamonga
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77988
- Address
- 11570 6th St
- Code information
- Lot # XI002A6, XI003A6, Exp 12/17; XI004G6, XI005G6, Exp 6/18; XI007H6, Exp 7/18; XI00816, XI00916, XI01016, XI01116, Exp 8/18; XI012J6, XI013J6, Exp 9/18; XI015K6, Exp 10/18; XI016L6, Exp 11/18; XL018A7, XI019A7, Exp 12/18; XI020B7, XI021B7, Exp 1/19; XI022C7, XI023C7, Exp 2/19; XI025D7, Exp 3/19.
- Postal code
- 91730-6025
- Report date
- Sep 6, 2017
- Product type
- Drugs
- Recall number
- D-1124-2017
- Classification
- Class II
- Recalling firm
- Amphastar Pharmaceuticals, Inc.
- Product quantity
- 637,810 vials
- Termination date
- Jan 14, 2019
- Reason for recall
- Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
- Distribution pattern
- Distributed throughout the United States
- Recall initiation date
- Aug 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2017