FDA-Drug2015-08-12Class II

SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97

The Apothecary Shoppe LLC
Hazard

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Sold states
Oklahoma
Affected count
378 mL
Manufactured in
6136 E 51st St, N/A, Tulsa, OK, United States
Products
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1297-2015

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