D-0714-2016 Class II Terminated
FDA drug recall D-0714-2016 was initiated by Abbott's Compounding Pharmacy, Inc. on January 15, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. The recall status is terminated (terminated April 6, 2017). Affected quantity: 10 ml.
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- January 15, 2016
- Termination Date
- April 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 ml
Product Description
papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Reason for Recall
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Distribution Pattern
CA
Code Information
All lots