SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling two bags of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride because they were made with recalled saline bags that 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 non-sterile medical products.
Plain-English summary
SCA Pharmaceuticals is recalling two bags of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride (NDC: 70004-0810-32). The product is a 100 mL single-dose container bag intended for prescription use only. The specific lot number is 20170710@3, and the beyond-use date is 10/8/2017.
The recall was initiated due to a lack of assurance of sterility. The product was manufactured using recalled 0.9% sodium chloride bags that have the potential to leak. This defect compromises the sterility of the final product.
The affected product was distributed nationwide in the USA. Healthcare providers and patients should stop using the affected bags and contact SCA Pharmaceuticals at (877) 550-5059 for further instructions.
The recalled product
- Product
- PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 2
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)
- Lot: 20170710@3
- BUD: 10/8/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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