SCA Pharmaceuticals Recalls Phenylephrine HCl Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl injection because the product lacks assurance of sterility and has the potential to 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 a lack of sterility assurance in an injectable product.
Plain-English summary
SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, a prescription-only medication. The recall is being conducted because the product lacks assurance of sterility and has the potential to leak.
The affected product is identified by NDC# 70004-0809-40. The specific lots subject to this recall are 20170502@53 with a best-use date of 7/31/2017, and 20170505@16 with a best-use date of 8/3/2017. The distribution pattern for these products is nationwide.
Consumers and healthcare providers should check their inventory for these specific lot numbers and best-use dates. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.
The recalled product
- Product
- PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- 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: 20170502@53 BUD: 7/31/2017
- 20170505@16 BUD: 8/3/2017
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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