Advanced Pharma Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns
Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution because there is 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, particularly given the risk of infection from non-sterile IV medication.
Plain-English summary
Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL). The product is a 5mL sterile single-use syringe intended for intravenous (IV) use only. The recall is being conducted due to a lack of assurance of sterility.
The affected lots include 11/02/18 9350 82967S (Exp. 4/1/2019), 10/23/18 1471 82967S (Exp. 3/22/2019), 10/24/18 4412 82967S (Exp. 3/23/2019), and 10/24/18 0733 82967S (Exp. 3/22/2019). The product was distributed nationwide.
Healthcare providers and consumers should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 or Avella of Houston at 9265 Kirby Dr., Houston, TX 77054 for further instructions.
The recalled product
- Product
- Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 5,700
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 (4)
- Lots: 11/02/18 9350 82967S Exp. 4/1/2019
- 10/23/18 1471 82967S Exp. 3/22/2019
- 10/24/18 4412 82967S Exp. 3/23/2019
- 10/24/18 0733 82967S Exp. 3/22/2019
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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