Hikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling 101,710 shelf-packs of Ketorolac Tromethamine Injection, USP 30 mg/mL. The product is packaged in 1 mL single-dose vials and is intended for intravenous or intramuscular use only. The recall covers specific lots with expiration dates ranging from March 2020 to February 2021.
The recall was initiated due to the presence of particulate matter, specifically particles identified as polydimethylsiloxane (PDMS). The affected product was distributed nationwide within the United States.
Healthcare providers and patients should discontinue use of the affected lots. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Prescription Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Lot #: 038366
- Exp. Date Mar 2020
- 048365
- 048367
- Exp. Date Apr 2020
- 078301
- 078303
- Exp. Date July 2020
- 118358
- Exp. Date Nov 2020
- 029353
- Exp. Date Feb 2021
- 019413
- Exp. Date Jan 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hikma Pharmaceuticals USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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