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Promise Pharmacy, LLC

FDA Regulatory Profile

Promise Pharmacy, LLC has 53 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0803-2021 · Class II · Jun 30, 2021
Latest inspection
Sep 23, 2021 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls53Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0803-2021Class IIMIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10…Jun 30, 2021
D-0445-2019Class IIGlutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US…Dec 17, 2018
D-0431-2019Class IIAcetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding…Dec 17, 2018
D-0432-2019Class IIPrednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded…Dec 17, 2018
D-0433-2019Class IIPrednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded…Dec 17, 2018
D-0471-2019Class IIZinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818…Dec 17, 2018
D-0451-2019Class IISermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists…Dec 17, 2018
D-0465-2019Class IIMelanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N…Dec 17, 2018
D-0479-2019Class IIGlycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists…Dec 17, 2018
D-0438-2019Class IIVitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25…Dec 17, 2018
D-0439-2019Class IIMulti Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only…Dec 17, 2018
D-0453-2019Class IIIpamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm…Dec 17, 2018
D-0457-2019Class IIEpithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm…Dec 17, 2018
D-0468-2019Class IINicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy…Dec 17, 2018
D-0464-2019Class IIIGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm…Dec 17, 2018
D-0469-2019Class IINiacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818…Dec 17, 2018
D-0455-2019Class IIIpamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N…Dec 17, 2018
D-0448-2019Class IISermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding…Dec 17, 2018
D-0475-2019Class IIPyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists…Dec 17, 2018
D-0435-2019Class IIPrednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx…Dec 17, 2018

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 23, 2021Palm Harbor, FLDrugsVoluntary Action Indicated (VAI)3013207472
Oct 25, 2018Palm Harbor, FLDrugsOfficial Action Indicated (OAI)3013207472

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3013207472Palm Harbor, FL2Sep 23, 2021

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.