Recalls / Class II
Class IID-0496-2019
Product
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72
- Affected lot / code info
- Lot#: 12/31/18 0555 21072S, Exp 3/31/2019
Why it was recalled
Labeling: Incorrect expiration date.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 100 syringes
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2019-02-06
- FDA classified
- 2019-02-15
- Posted by FDA
- 2019-02-27
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0496-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.