Morphine Sulfate 4 mg/mL PF Injection recalled over sterility concerns

Recall date

April 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Premier Pharmacy Labs Inc recalls Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL…

Recall number

D-0700-2018

FDA classification

Class II

Brand / firm

Premier Pharmacy Labs Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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