Advanced Pharma Recalls Esmolol HCl Injectable Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 550 syringes of Esmolol HCl Injectable Solution due to a lack of assurance of sterility. The affected products were 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports, or high-risk contamination.
Plain-English summary
Advanced Pharma Inc. is recalling 550 syringes of Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL). The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is identified by the NDC 42852-827-61 and the lot code 11/06/18 5007 82761S, with an expiration date of 4/5/2019. The recall covers 550 syringes that were distributed nationwide.
Healthcare providers and consumers should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions.
The recalled product
- Product
- Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 550
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: 11/06/18 5007 82761S Exp. 4/5/2019
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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