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 II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), as the rule states that if the agency's own classification is FDA Class I or II, the score must not be below 4.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials. The recall involves 25,817 shelf packs, with 25 vials per pack. The product is distributed nationwide within the United States.
The recall was initiated due to the presence of particulate matter, specifically particles identified as polydimethylsiloxane (PDMS). The affected lots include codes 038368 (Exp. Mar 2020), 058314 (Exp. May 2020), 078305 and 078307 (Exp. July 2020), and 118362 (Exp. Nov 2020).
Healthcare providers and patients should check their inventory and medication vials for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should not be used. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injection
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 (8)
- 038368
- Exp. Mar 2020
- 058314
- Exp. May 2020
- 078305
- 078307
- Exp. July 2020
- 118362 Exp. Nov 2020
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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