Advanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,850 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, which corresponds to a 'Severe' severity score under the rubric for significant injury/property-damage reports or high-risk scenarios.
Plain-English summary
Advanced Pharma Inc. is recalling 1,850 syringes of Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution. The product is identified by NDC 42852-802-61 and Lot 11/01/18 8847 80261S, with an expiration date of 3/31/2019.
The recall was initiated due to a lack of assurance of sterility. The affected product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions.
The recalled product
- Product
- Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 1,850
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)
- Lot: 11/01/18 8847 80261S Exp. 3/31/2019
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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