Recalls / Class II
Class IID-0019-2018
Product
Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
- Affected lot / code info
- Lot #: 041817S5, Exp 10/15/2017; 052417S2, Exp 11/20/2017; 071117S4, Exp 1/7/2018; 0712217S4, Exp 1/8/2018; 080317S6, Exp 1/30/2018; 082217S5, Exp 2/1/2018
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- Banner Pharmacy Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7300 W Detroit St, N/A, Chandler, Arizona 85226-2410
Distribution
- Quantity
- 1658 syringes
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-10-10
- FDA classified
- 2017-10-23
- Posted by FDA
- 2017-11-01
- Terminated
- 2018-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0019-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.