Pfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects
Pfizer is recalling 38,676 trays of Fentanyl Citrate Injection vials because loose metal overseal crimps may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (loss of sterility assurance) poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Pfizer Inc. is recalling 38,676 trays of Fentanyl Citrate Injection, USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vials. The product is distributed by Hospira, Inc. and is intended for intravenous or intramuscular use. The affected lots are 08133DK (tray) / 08-133-DK (vial) and 08134DK (tray) / 08-134-DK (vial), with an expiration date of 2/1/2021.
The recall was initiated due to confirmed customer reports of vials with loose metal overseal crimp defects. These defects may result in a lack of assurance of sterility for the medication. The product was distributed nationwide in the U.S. and Puerto Rico.
Healthcare providers and patients should check their inventory for the specific lot numbers listed above. If the product is found, it should be quarantined and not used. Patients who have already received the medication should contact their healthcare provider for guidance.
The recalled product
- Product
- Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable
- Affected units
- 38,676
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 #s: 08133DK (tray) 08-133-DK (vial)
- 08134DK (tray) 08-134-DK (vial)
- Exp. 2/1/2021.
Distribution
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