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FDAApril 11, 2018drug

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

premier pharmacy labspremierpremier pharmacy

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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