Ketorolac injection vials recalled after glass particulate found in product
Aspiro Pharma is recalling Ketorolac Tromethamine Injection USP 60 mg/2 mL across several lots because of particulate matter identified as glass.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: glass particulate in an injectable is a physical hazard, and no injuries are reported.
Plain-English summary
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), in 2 mL single-dose vials for intramuscular use, manufactured by Aspiro Pharma Limited in Telangana, India for Camber Pharmaceuticals of Piscataway, New Jersey, is being recalled for the presence of particulate matter identified as glass.
The recall covers lots including AS1240347A (expiring September 2026), AS1240144A (expiring May 2026) and AS1240145A and AS1240146A (expiring June 2026). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Glass particulate in an injectable product is a physical hazard because the drug is administered directly into muscle. The enforcement record reports no injuries.
Facilities holding an affected lot should quarantine it and follow the firm's instructions.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Aspiro Pharma Limited
- Category
- Drug — Injectable
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 (9)
- Lot #: AS1240347A
- Exp Date 09/2026
- AS1240144A
- Exp Date 05/2026
- AS1240145A
- AS1240146A
- Exp Date 06/2026
- AS1250295A
- Exp Date 05/2027.
Distribution
Distributed nationwide across the United States.
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