D-1296-2015 Class II Terminated
FDA drug recall D-1296-2015 was initiated by The Apothecary Shoppe LLC on June 26, 2015 and is designated Class II. 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. The recall status is terminated (terminated February 17, 2017). Affected quantity: 70 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- August 12, 2015
- Initiation Date
- June 26, 2015
- Termination Date
- February 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 mL
Product Description
SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
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.
Distribution Pattern
Oklahoma
Code Information
Lot #s: 03102015@30, BUD 7/8/2015; 04162015@30, BUD 10/13/2015