Home / Recalls / Promise Pharmacy, LLC / D-0437-2019

D-0437-2019 Class II Terminated

Recalled by Promise Pharmacy, LLC — Palm Harbor, FL

Recall Details

Product Type
Drugs
Report Date
February 20, 2019
Initiation Date
December 17, 2018
Termination Date
March 30, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
167 3 ml bottles

Product Description

Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019

Other recalls by Promise Pharmacy, LLC

  • D-0803-2021 Class II — MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg (June 30, 2021)
  • D-0480-2019 Class II — Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding (December 17, 2018)
  • D-0433-2019 Class II — Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx (December 17, 2018)
  • D-0464-2019 Class II — IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 318 (December 17, 2018)
  • D-0432-2019 Class II — Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx (December 17, 2018)
  • D-0470-2019 Class II — Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vi (December 17, 2018)
  • D-0466-2019 Class II — ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chr (December 17, 2018)
  • D-0471-2019 Class II — Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding (December 17, 2018)
  • D-0463-2019 Class II — Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 3 (December 17, 2018)
  • D-0472-2019 Class II — Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compoundin (December 17, 2018)