September 08, 2017
Amphastar Pharmaceuticals Inc. is voluntarily recalling 20 lots of 1-mL single-dose vials of ketorolac tromethamine injection, USP, 30 mg/mL (NDC 0548-9021-00), because some retained samples contained ketorolac calcium salt.
The recall was included in the September 6, 2017, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 637,810 vials distributed across the United States from the following lots:
- XI002A6 and XI003A6 (Exp. 12/17);
- XI004G6 and XI005G6 (Exp. 6/18);
- XI007H6 (Exp. 7/18);
- XI00816, XI00916, XI01016, and XI01116 (Exp. 8/18);
- XI012J6 and XI013J6 (Exp. 9/18);
- XI015K6 (Exp. 10/18);
- XI016L6 (Exp. 11/18);
- XL018A7 and XI019A7 (Exp. 12/18);
- XI020B7 and XI021B7 (Exp. 1/19);
- XI022C7 and XI023C7 (Exp 2/19); and
- XI025D7 (Exp. 3/19).
Amphastar initiated the recall August 15, 2017. The FDA designated it Class II August 29, 2017, suggesting use of affected vials could cause temporary or reversible adverse effects. The likelihood of serious harm, however, is remote.
Ketorolac tromethamine injection is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of moderately severe acute pain that requires analgesia at the opioid level.