SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine 100 mg injection bags because they lack assurance of sterility and may leak.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from lack of sterility.
Plain-English summary
SCA Pharmaceuticals is recalling Phenylephrine 100 mg in 0.9% Sodium Chloride 250 mL Bags (NDC 70004-0813-40). The recall is due to a lack of assurance of sterility and the potential for the product to leak.
The affected product is a prescription-only medication distributed nationwide. The specific lot number is 20170503@16, with a beyond-use date of August 1, 2017.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- Hazard
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 (1)
- Lot: 20170503@16 BUD: 8/1/2017
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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