The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0420-2015·Announced 2015-04-01

West-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures

West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.

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 failure of impurity and stability specifications represents a quality control issue that warrants a moderate severity rating under the rubric for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

West-Ward Pharmaceutical Corporation is recalling Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials. The product is intended for intravenous or intramuscular use and is preservative-free. The recall covers 445,475 vials distributed nationwide.

The recall was initiated because the product failed impurities and degradation specifications as well as 12-month stability testing. The affected lots are 113312 (Exp 11/2015) and 014315 (Exp 01/2016). The FDA has classified this recall as Class III.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
FENTANYL CITRATE (FENTANYL CITRATE)
Brand
FENTANYL CITRATE
Manufacturer
West-Ward Pharmaceutical Corporation
Category
Drug — Prescription Injection
Hazard
Affected units
445,475

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 (3)

  • Lot #: 113312
  • Exp 11/2015
  • 014315 Exp 01/2016

Distribution

Distributed nationwide across the United States.

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