Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 180 bags of fentanyl 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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Advanced Pharma Inc. is recalling 180 bags of fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags (NDC: 42852-210-25). The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by Lot 01/03/19 1645 21025P with an expiration date of 5/3/2019. The product was distributed nationwide.
Healthcare providers and facilities should stop using the affected product and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions.
The recalled product
- Product
- fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 180
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: 01/03/19 1645 21025P Exp. 5/3/2019
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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