Prescription NSAID Recalled

October 10, 2017

RemedyRepack Inc. is recalling 40 vials of ketorolac tromethamine 30 mg/mL injection, according to the October 4, 2017, US Food and Drug Administration (FDA) Enforcement Report. The recall was prompted by crystalline ketorolac calcium salt that was visible in the vials.

The product was packaged by RemedyRepack Inc. and manufactured by Amphastar.

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The recall affects ketorolac tromethamine 30 mg/mL injection packaged in 1-mL vials (NDC 61786-0741-01, originally 00548-9021-00) from lot B0158730-060816 (manufacturer XI002A6) and cartons of 10 1-mL vials (NDC 61786-0741-08, originally 00548-9021-00) from lot B0160669-061516 (manufacturer XI003A6). Both lots have a December 2017 expiration date and were distributed to a consignee in Louisiana.

RemedyRepack Inc. issued the voluntary recall August 22, 2017. The FDA designated it Class II September 22, 2017, suggesting use of the affected product could cause temporary or reversible adverse effects. The probability of serious harm is remote.

Ketorolac tromethamine injection is a prescription-only nonsteroidal anti-inflammatory drug used for the short-term management of moderately severe pain, typically after surgery.

Jolynn Tumolo