Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.
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 22,900 syringes of Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution. The product is identified by NDC 42852-830-61 and is distributed nationwide.
The recall was initiated because of a lack of assurance of sterility. The affected lots have expiration dates ranging from March 17, 2019, to April 5, 2019.
Healthcare providers and facilities should stop using the affected product and contact Advanced Pharma Inc. for further instructions.
The recalled product
- Product
- Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 22,900
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 (12)
- Lots: 10/24/18 3318 83061S Exp. 3/23/2019
- 10/18/18 3354 83061S Exp. 3/17/2019
- 10/23/2018 6050 83061S Exp. 3/22/2019
- 10/23/18 8105 83061S Exp. 3/22/2019
- 10/18/18 1961 83061S Exp. 3/17/2019
- 10/18/18 2598 83061S Exp. 3/17/2019
- 11/05/18 1184 83061S Exp. 4/4/2019
- 10/22/18 0737 83061S Exp. 3/21/2019
- 10/25/18 1198 83061S Exp. 3/24/2019
- 11/06/18 4451 83061S Exp. 4/5/2019
- 11/06/18 0108 83061S Exp. 4/5/2019
- 10/22/18 1530 83061S Exp. 3/21/2019
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.
See all 19 products in this recall →Related recalls
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