Fentanyl Citrate Inj recall: Impurity Out of Spec
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative…
Why was Fentanyl Citrate Inj recalled?
Failed Impurities/Degradation Specifications; 12 month stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
- Product
- Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative…
- Recalling firm
- West-Ward Pharmaceutical Corporation
- Quantity
- 445,475 Vials
- Distribution
- Nationwide
- Recall date
- April 1, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)