SCA Pharmaceuticals Recalls Phenylephrine HCl Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
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 a lack of sterility assurance in an injectable product.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, a prescription-only medication. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected product is identified by NDC# 70004-0810-40. The specific lots subject to this recall are 20170512@20 with a beyond-use date of 8/10/2017, and 20170504@61 with a beyond-use date of 8/2/2017. The distribution pattern for this product is nationwide.
Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication for the specific lot numbers and beyond-use dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- 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 (2)
- Lots: 20170512@20 BUD: 8/10/2017
- 20170504@61 BUD: 8/2/2017
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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