PlainRecalls
FDA Drug Moderate Class II Terminated

SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34

Reported: August 12, 2015 Initiated: June 26, 2015 #D-1291-2015

Product Description

SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34

Reason for Recall

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

Details

Recalling Firm
The Apothecary Shoppe LLC
Units Affected
1200.4 mL
Distribution
Oklahoma
Location
Tulsa, OK

Frequently Asked Questions

What product was recalled?
SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34. Recalled by The Apothecary Shoppe LLC. Units affected: 1200.4 mL.
Why was this product recalled?
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 12, 2015. Severity: Moderate. Recall number: D-1291-2015.