FDAApril 4, 2022drug

Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

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

The hazard

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

What to do

FDA enforcement status: Terminated

Brands named

olympia compounding pharmacy dba olympia pharmacyolympiaolympia compounding

UPCs

7319800600073198005900

Recall history

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

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Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. — Recall Details · AllClear