Recalls / Class II
Class IID-0133-2019
Product
Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
- Affected lot / code info
- Lot # 8/27/18 0215 22110P, Exp 12/10/2018
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- Avella of Deer Valley, Inc. Store 38
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave, N/A, Phoenix, Arizona 85085-1887
Distribution
- Quantity
- 360 bags
- Distribution pattern
- U.S.A. nationwide.
Timeline
- Recall initiated
- 2018-10-19
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2021-05-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0133-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.