SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL bags because they may leak and lack assurance of 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk structural defects (leaking/sterility) are rated as Severe (4).
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL bags, preservative-free, prescription only. The recall is due to a lack of assurance of sterility and the potential for the product to leak.
The affected product is identified by NDC# 70004-0811-40. The specific lots subject to the recall are 20170503@26 with a beyond-use date of 8/1/2017, and 20170510@48 with a beyond-use date of 8/8/2017. The product was distributed nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals for further instructions or replacement.
The recalled product
- Product
- PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Solution
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)
- Lots: 20170503@26 BUD: 8/1/2017
- 20170510@48 BUD: 8/8/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 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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