FDAApril 18, 2017drug

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

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

The hazard

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

What to do

FDA enforcement status: Terminated

Brands named

key pharmacy and compounding centerkeykey pharmacy

Recall history

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

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