SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Seam Leaks
SCA Pharmaceuticals is recalling 118 bags of fentanyl injection due to seam leaks that compromise sterility. The product was distributed nationwide in the USA.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
SCA Pharmaceuticals is recalling 118 bags of fentaNYL (as citrate) in 0.9% Sodium Chloride injectable, 10 mcg per mL, 100 mL single-dose containers. The recall is due to product bags leaking at the seam, which creates a lack of assurance of sterility.
The affected product is identified by NDC 70004-0229-32. The specific lots involved are 20170505@14 with a use-by date of 08/03/17, and 20170510@2 with a use-by date of 08/08/17. The product was distributed nationwide in the USA.
Healthcare providers and patients should stop using the affected fentanyl injection bags and contact SCA Pharmaceuticals for further instructions or a 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 70004-0229-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Affected units
- 118
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 # 20170505@14
- Use By: 08/03/17
- 20170510@2
- Use By: 08/08/17
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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