D-1299-2015 Class II Terminated
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
- 2.5 mL
Product Description
SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01
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 #: 04082015@37, BUD 10/05/2015