SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising 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 source text indicates a lack of assurance of sterility for an injectable product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant harm).
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 370 bags of fentaNYL (as citrate) in 0.9% Sodium Chloride injectable, 10 mcg per mL, 100 mL single-dose containers. The product is identified by NDC 70004-0202-32, Lot # 20170506@14, and has a use-by date of 08/04/17.
The recall was initiated due to a lack of assurance of sterility, specifically because the product bags were found to be leaking at the seam. This defect poses a risk of contamination to the injectable solution.
The affected product was distributed nationwide in the USA. Healthcare providers and patients should stop using the recalled product and contact SCA Pharmaceuticals for further instructions or replacement.
The recalled product
- Product
- fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 370
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)
- LOT # 20170506@14
- Use By: 08/04/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals 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.
See all 10 products in this recall →Related recalls
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