Advanced Pharma Recalls Subpotent Fentanyl Citrate Prefilled Syringes
Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl citrate because the final drug concentration is subpotent compared to the label.
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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by subpotent opioid) are rated as Severe.
Plain-English summary
Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL (10 mcg per mL). The recall is due to the final drug concentration being subpotent as compared to the concentration indicated on the label.
The affected product is identified by Lot # 6/12/18 0432 149-21072S with a beyond-use date of 9/10/18. The product was distributed to one medical center in Fort Worth, TX.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Prefilled Syringe
- Hazard
- Affected units
- 100
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 (2)
- Lot #: 6/12/18 0432 149-21072S
- BUD 9/10/18
Distribution
Distribution scope not specified by the agency.
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