Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.
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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Advanced Pharma Inc. is recalling 360 bags of fentaNYL 1000 mcg/100 mL Injectable Solution (NDC: 42852-210-10). The product is a sterile single-use bag containing fentanyl in 0.9% Sodium Chloride. The recall is being conducted because of a lack of assurance of sterility.
The affected product is identified by Lot 01/03/19 1311 21010P with an expiration date of 5/3/2019. The recall is distributed nationwide. The FDA has classified this recall as Class II.
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
- fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 360
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 1311 21010P 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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