SCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl citrate injectable bags because they are leaking at the seam, which compromises 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 involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
SCA Pharmaceuticals is recalling 100 bags of fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable, 20 mcg per mL, Single Dose Container bag. The product is identified by NDC 70004-203-32, Lot # 20170508@59, and a Use By date of 08/06/17.
The recall was initiated due to a lack of assurance of sterility, as the product bags were found to be leaking at the seam. This defect poses a risk of contamination to the injectable medication.
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.
The recalled product
- Product
- fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 100
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 # 20170508@59
- Use By: 08/06/17
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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