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.
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' 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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