Advanced Pharma Recalls Phenylephrine HCl Injectable Syringes for Sterility Concerns
Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl Injectable Solution due to a lack of assurance of sterility. The product was distributed nationwide.
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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution. The specific product is a 10mL sterile single-use syringe with NDC 42852-865-61. The recall is being conducted because of a lack of assurance of sterility.
The affected lot is identified as 10/17/18 2976 86561S, with an expiration date of 3/16/2019. The product was distributed nationwide. The FDA has classified this recall as Class II.
Healthcare providers and patients should stop using the affected product and contact Advanced Pharma Inc. for further instructions. The company can be reached at (877) 794-0404 or at their address in Houston, TX.
The recalled product
- Product
- Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 800
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)
- Lots: 10/17/18 2976 86561S Exp. 3/16/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Advanced Pharma Inc. 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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