Advanced Pharma Recalls Midazolam Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,125 bags of Midazolam 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death from infection.
Plain-English summary
Advanced Pharma Inc. is recalling 1,125 bags of Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution. The product is distributed nationwide and is identified by NDC 42852-401-05. The recall is being conducted due to a lack of assurance of sterility.
The affected lots are 12/03/18 9479 40105P, 12/3/18 6583 40105P, 12/3/18 8918 40105P, and 12/03/18 4727 40105P, all with an expiration date of 4/2/2019. The product is a sterile single-use bag containing Midazolam HCl and 0.9% Sodium Chloride.
Healthcare providers and facilities should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 1,125
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: 12/03/18 9479 40105P Exp. 4/2/2019
- 12/3/18 6583 40105P Exp. 4/2/2019
- 12/3/18 8918 40105P Exp. 4/2/2019
- 12/03/18 4727 40105P Exp. 4/2/2019
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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