SIH-Testosterone Cyp. 200 mg/mL Injection recall: Sterility Concern
SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34
Why was SIH-Testosterone Cyp. 200 mg/mL Injection recalled?
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 04142015@5, BUD 8/12/2015; 04032015@23, BUD 7/2/2015; 04242015@28, BUD 8/22/2015
- Product
- SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34
- Recalling firm
- The Apothecary Shoppe LLC
- Quantity
- 1200.4 mL
- Distribution
- Oklahoma
- Recall date
- August 12, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)