Drug product
Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02
D-0255-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,118 syringes
- Official record key
drug-enforcement:D-0255-2016
Official wording
Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Code information: Lot Numbers: 20150906@32 BUD: 12/6/2015, 20150906@33 BUD: 12/6/2015, 20151105@45 BUD: 11/7/2015, 20151205@12 BUD: 11/8/2015, 20151404@39 BUD: 10/11/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility