Palm Harbor, FL, United States
Promise Pharmacy, LLC recalls
3 recalls recorded since 2018, most recently on 30 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 30 June 2021
- Terminated
- 6 June 2023
- Reason
- Lack of processing controls
- Distribution
- AZ, CO, FL, IL, NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0803-2021
- MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
Terminated Class II Drugs
- Recall started
- 17 December 2018
- Terminated
- 30 March 2021
- Reason
- Lack of sterility assurance.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0431-2019, D-0479-2019, D-0471-2019, D-0478-2019, D-0447-2019, D-0438-2019, D-0459-2019, D-0452-2019, D-0436-2019, D-0481-2019, D-0477-2019, D-0467-2019 and 39 more
- Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
- Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US
- BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- and 43 more product lines
Terminated Class III Drugs
- Recall started
- 18 October 2018
- Terminated
- 22 October 2020
- Reason
- Presence of precipitate
- Distribution
- U.S.A. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0239-2019
- Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.