Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.
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 for a sterile injectable product due to a lack of sterility assurance, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution. The product is distributed in sterile single-use syringes with the NDC 42852-876-61. The recall was initiated because the company lacks assurance of the product's sterility.
The affected lots are 10/18/18 1430 87661S (Expiration 3/17/2019) and 10/29/18 1805 87661S (Expiration 3/28/2019). The product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions. The company is located at 9265 Kirby Dr., Houston, TX 77054.
The recalled product
- Product
- Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 1,575
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)
- Lots: 10/18/18 1430 87661S Exp. 3/17/2019
- 10/29/18 1805 87661S Exp. 3/28/2019
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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