Drug product
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
D-0200-2017
Product summary
- Event
- Event 75745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,547 syringes
- Official record key
drug-enforcement:D-0200-2017
Official wording
Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Code information: Lot: 8997 BUD: 12/1/2016, Lot: 9246 BUD: 1/23/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility