Drug product
Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
D-0271-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,640 syringes
- Official record key
drug-enforcement:D-0271-2016
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 Code: 20150106@48 BUD: 11/28/2015, 20150106@49 BUD: 11/28/2015, 20150306@37 BUD: 11/30/2015, 20150906@50 BUD: 12/6/2015, 20150906@7 BUD: 12/5/2015, 20151208@32 BUD: 2/8/2016, 20152304@2 BUD: 10/20/2015, 20152804@6 BUD:10/24/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility