Recalls / Class II
Class IID-0889-2018
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.
- Affected lot / code info
- Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
Why it was recalled
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 100 syringes
- Distribution pattern
- Distributed to one medical center in Fort Worth, TX.
Timeline
- Recall initiated
- 2018-06-20
- FDA classified
- 2018-06-25
- Posted by FDA
- 2018-07-04
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0889-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.