Home / Recalls / Promise Pharmacy, LLC / D-0431-2019

D-0431-2019 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
75 10 ml bottles

Product Description

Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot: 11072018@10 BUD: 12/22/2018

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-0432-2019 Class II — Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx (December 17, 2018)
  • D-0457-2019 Class II — Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 318 (December 17, 2018)
  • D-0479-2019 Class II — Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compou (December 17, 2018)
  • D-0438-2019 Class II — Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiami (December 17, 2018)
  • D-0439-2019 Class II — Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 (December 17, 2018)
  • D-0451-2019 Class II — Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compound (December 17, 2018)
  • D-0435-2019 Class II — Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, (December 17, 2018)
  • D-0461-2019 Class II — HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharm (December 17, 2018)
  • D-0464-2019 Class II — IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 318 (December 17, 2018)