Drug product
NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.
D-0702-2018
Product summary
- Event
- Event 79803
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 syringes
- Official record key
drug-enforcement:D-0702-2018
Official wording
Reason: Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Code information: Lot: NEO022218SVDS BUD: 8/21/2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination
-
Sterility assurance
Lack of Assurance of Sterility