D-1295-2015 Class II Terminated
FDA drug recall D-1295-2015 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: 20 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
- 20 mL
Product Description
SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
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 #: 04232015@22, BUD 10/20/2015