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FDAMarch 14, 2016drug

Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

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

The hazard

Lack of Assurance of Sterility: incomplete or missing data regarding production.

What to do

FDA enforcement status: Terminated

Brands named

meditech laboratoriesmeditech

Recall history

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

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