Home / Recalls / Fallon Wellness Pharmacy, L.L.C. / D-0173-2017

D-0173-2017 Class II Terminated

Recalled by Fallon Wellness Pharmacy, L.L.C. — Latham, NY

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

Other recalls by Fallon Wellness Pharmacy, L.L.C.

  • D-0174-2017 Class II — PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL In (November 2, 2016)
  • D-1072-2015 Class II — Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Welln (March 17, 2015)
  • D-1066-2015 Class II — Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Well (March 17, 2015)
  • D-1070-2015 Class II — Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness (March 17, 2015)
  • D-1071-2015 Class II — Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellnes (March 17, 2015)
  • D-1074-2015 Class II — Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mc (March 17, 2015)
  • D-1068-2015 Class II — Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/m (March 17, 2015)
  • D-1069-2015 Class II — Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness (March 17, 2015)
  • D-1073-2015 Class II — Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness (March 17, 2015)
  • D-1075-2015 Class II — Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon (March 17, 2015)