D-0173-2017 Class II Terminated
FDA drug recall D-0173-2017 was initiated by Fallon Wellness Pharmacy, L.L.C. on November 2, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. The recall status is terminated (terminated June 19, 2018). Affected quantity: 10 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- December 14, 2016
- Initiation Date
- November 2, 2016
- Termination Date
- June 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 vials
Product Description
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Reason for Recall
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Distribution Pattern
NY
Code Information
Lot #: 09192016@41,09192016@69, Exp 11/04/2016