Injectable ketorolac tromethamine recalled nationwide for potential cross-contamination
Nephron Pharmaceuticals is recalling Ketorolac Tromethamine Injection due to manufacturing deviations that could lead to cross-contamination. The recall affects 5,040 vials distributed nationwide.
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: FDA Class II recall for an injectable pharmaceutical with potential cross-contamination resulting from manufacturing deviations. While no illnesses or injuries have been reported, injectable products with manufacturing defects present a risk of harm.
Plain-English summary
Ketorolac Tromethamine Injection, USP (60 mg/2 mL) manufactured by Nephron Pharmaceuticals Corporation is being recalled. The affected product is packaged in 2 mL single-dose vials with lot number 023011 (expiration date August 31, 2022).
The recall is due to cGMP deviations that could lead to potential cross-contamination. The FDA has classified this as a Class II recall.
The recall affects 5,040 vials distributed nationwide.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Nephron Sc Inc
- Category
- Drug — Injectable
- Affected units
- 5,040
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 (1)
- Lot#: 023011 Exp 8/31/2022
Distribution
Distributed nationwide across the United States.
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