Sagent Recalls Ketorolac Tromethamine Injection Due to Incorrect Expiration Date Labeling
Sagent Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because the products were labeled with incorrect expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Sagent Pharmaceuticals Inc is recalling 69,050 vials of Ketorolac Tromethamine Injection, USP, 30 mg per mL. The affected products are available in 1 mL and 2 mL vials and are distributed nationwide and in Puerto Rico. The recall involves Lot MP5021 with an expiration date of 04/16, and Lots MP5024 and MP5025 with an expiration date of 05/16.
The recall was initiated because the products were labeled with incorrect expiration dates. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If these products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Injection
- Hazard
- Affected units
- 69,050
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 (5)
- Lot MP5021
- Exp. 04/16
- Lots MP5024
- MP5025
- Exp. 05/16
Distribution
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