SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
What this means for you
Illness, injury, or structural failure has been reported. 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 in an injectable product.
Plain-English summary
SCA Pharmaceuticals is recalling specific lots of Phenylephrine 40 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 number 70004-0812-40. The specific lots involved are 20170429@28 with a best-use date of July 28, 2017, and 20170509@65 with a best-use date of August 7, 2017. The distribution pattern for this recall is nationwide.
Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions. Consumers should not use the product if it is found to be leaking or if sterility cannot be assured.
The recalled product
- Product
- PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
- 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: 20170429@28 BUD: 7/28/2017
- BUD: 20170509@65 BUD: 8/7/2017
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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