Recalls / Class II
Class IID-0659-2022
Product
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Affected lot / code info
- Lot #: 08022020@1 BUD: 8/17/2020
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Family Pharmacy of Statesville
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 3478 E Broad St, N/A, Statesville, North Carolina 28625-4523
Distribution
- Quantity
- 1 bag
- Distribution pattern
- NC only
Timeline
- Recall initiated
- 2020-08-06
- FDA classified
- 2022-03-17
- Posted by FDA
- 2022-03-23
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0659-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.