Drug product
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.
D-0173-2017
Product summary
- Event
- Event 75695
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 vials
- Official record key
drug-enforcement:D-0173-2017
Official wording
Reason: Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Code information: Lot #: 09192016@41,09192016@69, Exp 11/04/2016
Distribution pattern: NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility