D-1120-2015 Class II Terminated
FDA drug recall D-1120-2015 was initiated by Montana Compounding Pharmacy on May 15, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection The recall status is terminated (terminated December 20, 2016). Affected quantity: 1/5mL vial.
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2015
- Initiation Date
- May 15, 2015
- Termination Date
- December 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1/5mL vial
Product Description
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Distribution Pattern
MT and ND
Code Information
Lot 04102015:18@15, expiry date: 7/3/2015