Home / Recalls / Promise Pharmacy, LLC / D-0443-2019

D-0443-2019 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
704 vials

Product Description

Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: 08032018@3 BUD: 01/30/2019; 08272018@6 BUD: 2/23/2019; 09142018@4 BUD: 3/13/2019; 10012018@3 BUD: 3/30/2019

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-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)