Recalls / Class II
Class IID-0174-2017
Product
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
- Affected lot / code info
- Lot #: 09202016@8, Exp 11/04/2016
Why it was recalled
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Recalling firm
- Firm
- Fallon Wellness Pharmacy, L.L.C.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1057 Troy Schenectady Rd, N/A, Latham, New York 12110-1002
Distribution
- Quantity
- 5 vials
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2016-11-02
- FDA classified
- 2016-12-08
- Posted by FDA
- 2016-12-14
- Terminated
- 2018-06-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0174-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.