West-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures
West-Ward Pharmaceutical Corp. is recalling Fentanyl Citrate Injection due to failed impurities and degradation specifications. The recall covers 14,649 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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 FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The hazard involves failed impurities and stability testing, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling Fentanyl Citrate Injection, USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton. The recall involves 14,649 cartons of the product, which was distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications and 12-month stability testing. This action is an expansion of a previous recall, RES #70548.
Affected lots include 043410, 053391, 073340, 083330, 083333, 083335, 093319, 093321, 093323, 103316, and 103318. Healthcare providers and pharmacies should stop using the affected product and contact West-Ward Pharmaceutical Corp. for further instructions.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 14,649
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 (17)
- Lot #: 043410
- Exp 04/2015
- 053391
- Exp 05/2015
- 073340
- Exp 07/2015
- 083330
- 083333
- 083335
- Exp 08/2015
- 093319
- 093321
- 093323
- Exp 09/2015
- 103316
- 103318
- Exp 10/2015
Distribution
Distributed nationwide across the United States.
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