Sagent Recalls Ketorolac Tromethamine Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling 75,825 vials of Ketorolac Tromethamine Injection because microbial growth was detected during a routine manufacturing simulation.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Sagent Pharmaceuticals Inc. is recalling 75,825 vials of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL). The affected product is identified by Lot # M813513 with an expiration date of February 2020. The medication is a prescription-only injectable used for intramuscular or intravenous administration.
The recall was initiated due to a lack of sterility assurance. Microbial growth was detected during a routine simulation of the manufacturing process, which indicates the potential introduction of microorganisms into the products. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The affected vials were distributed nationwide in the United States and Puerto Rico. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injectable
- Affected units
- 75,825
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 (2)
- Lot #: M813513
- Exp. Feb 2020
Distribution
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