Fallon Wellness Pharmacy recalls
Fallon Wellness Pharmacy appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2016-12-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2013-11-06 to 2016-12-14 |
| By agency | FDA Drug (13) |
| By classification | Class II (13) |
| By status | terminated (13) |
| Distribution named in notices | ME, NY |
Recalls
- PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 T…
FDA Drug · Class II · 2016-12-14 · Fallon Wellness Pharmacy
Reason: Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. - PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy…
FDA Drug · Class II · 2016-12-14 · Fallon Wellness Pharmacy
Reason: Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. - Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection…
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/…
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
FDA Drug · Class II · 2015-05-20 · Fallon Wellness Pharmacy
Reason: Lack of assurance of sterility - Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110
FDA Drug · Class II · 2013-11-06 · Fallon Wellness Pharmacy
Reason: Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing steril…