SIH-Testosterone Cyp recalled over sterility concerns
- Recall date
- June 26, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- The Apothecary Shoppe LLC recalls SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,…
- Recall number
- D-1293-2015
- FDA classification
- Class II
- Brand / firm
- The Apothecary Shoppe LLC
- Sold / distributed
- Oklahoma
Why it was recalled
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05
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