Camber Pharmaceuticals recalled Ketorolac Tromethamine Injection, USP, 60 mg/2 mL, 2 mL single-dose vials distributed nationwide in the United States. The recall is due to the presence of glass particulates. Healthcare providers and patients should stop using the product immediately and contact Aspiro Pharma Limited at 1-866-495-1995 for guidance.
Presence of Particulate Matter: Particulate matter identified as glass
Consumers and healthcare providers should stop using this product immediately. Contact Aspiro Pharma Limited or your healthcare provider for guidance. Notification method: Letter
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Ketorolac Tromethamine Injection is used under medical supervision for short-term pain relief. It is supplied in 2 mL single-dose vials for intramuscular use.
The presence of glass particulates in an injectable drug could cause tissue injury or other health risks if administered.
This recall is not described as part of a broader industry pattern in the notice.
If exposed, patients may need medical evaluation for potential glass-related injury and may require alternative analgesia.
NDC numbers on carton and vial labels; Lot numbers on vial label; Expiration dates on packaging
Recall processing and replacement timelines not specified. Expect manufacturer guidance.
Keep the recall notice, packaging, lot numbers, dates, and all correspondence with the manufacturer for records.
Product: Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL). Form: 2 mL single-dose vial. Route: Intramuscular. Rx only. Sold for Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. Manufactured by Aspiro Pharma Limited, Telangana - 502281, INDIA. NDC 31722-307-25 (Carton); 31722-307-02 (Vial label). Lots: AS1240347A, AS1240144A, AS1240145A, AS1240146A, AS1250295A. Exp: 09/2026, 05/2026, 06/2026, 05/2027. Recall date: 2025-10-01. Status: ACTIVE. Distribution: Nationwide in the United States. Contact: 1-866-495-1995. FDA recall number: D-0036-2026.
No injuries or incidents have been reported.
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