Multi-event November 2016 FDA Recall Drug by Fallon Wellness Pharmacy, L.l.c.
This Multi-event Class II drug recall was voluntarily initiated by Fallon Wellness Pharmacy, L.l.c. on November 2, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in NY and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0174-2017
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
11-02-2016
12-14-2016
5 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fallon Wellness Pharmacy, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NY
06-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 09202016@8, Exp 11/04/2016
Recall Number: D-0173-2017
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
11-02-2016
12-14-2016
10 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fallon Wellness Pharmacy, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NY
06-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 09192016@41,09192016@69, Exp 11/04/2016
