FDA-Drug2018-05-02Class II

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.

Premier Pharmacy Labs Inc
Hazard

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.

Sold states
Nationwide in the USA
Affected count
600 syringes
Manufactured in
8265 Commercial Way, N/A, Weeki Wachee, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0702-2018

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