FDA-Drug2018-05-02Class II
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
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
4192 syringes
Manufactured in
8265 Commercial Way, N/A, Weeki Wachee, FL, United States
Products
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0700-2018Don't want to check this manually?
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