Pfizer Recalls Fentanyl Citrate Injections Due to Sterility Assurance Concerns
Pfizer is recalling 19,144 vials of Fentanyl Citrate injection due to potential loose metal overseal crimp defects that 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectable drugs) are rated as Severe (4).
Plain-English summary
Pfizer Inc. is recalling 19,144 vials of Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials. The recall is being conducted because of a lack of assurance of sterility, potentially caused by loose metal overseal crimp defects. The affected product is distributed by Hospira, Inc. and is available in the United States, including Puerto Rico.
The specific lots involved are Tray lot 13405DK (Vial lot 13-405 DK, Exp. 1JUL2021) and Tray lot 17096DK (Vial lot 17-096-DK, Exp. 1NOV2021). The product is a prescription-only medication intended for intramuscular or intravenous use. The FDA has classified this recall as Class II, 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 listed above. If the product is found, it should be quarantined and not administered. Consumers and healthcare professionals should contact Pfizer or their local FDA office for further instructions on how to return or dispose of the recalled product.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- Pfizer Inc.
- Affected units
- 19,144
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 (2)
- Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021
- Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
Distribution
Distributed in 1 state:
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