Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl 2,500 mcg injection due to lack of sterility assurance. Affected batches were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable pharmaceutical with lack of sterility assurance presents significant risk due to direct bloodstream exposure. No reported illnesses or injuries and the hazard is theoretical rather than confirmed contamination, limiting score to 3 per rubric.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling fentanyl 2,500 mcg/50 mL injection (NDC 70004-0222-30). The recalled batches are Lot 1223048351 (expiration 11/30/23) and Lot 1223048532 (expiration 12/07/23), totaling 500 bags distributed nationwide.
The recall was initiated due to lack of assurance of sterility. Fentanyl is an intravenous medication, meaning it is injected directly into the bloodstream. Products lacking adequate sterility assurance can pose a risk of infection to patients.
The recalled product
- Product
- fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable / Opioid
- Hazard
- Affected units
- 500
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 (4)
- Lot #: 1223048351
- Exp 11/30/23
- 1223048532
- Exp 12/07/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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