SCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.
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 product, which meets the criteria for a Severe rating due to the potential for significant injury from contamination.
Plain-English summary
SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only. The product is identified by NDC 70004-0810-32, Lot # 20170511@17, and Use By date 08/09/17.
The recall was initiated due to a lack of assurance of sterility, specifically because the product bags are 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 affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Solution
- Affected units
- 30
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 # 20170511@17
- Use By: 08/09/17
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.
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