Category
Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIEpithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIIGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIIpamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIIpamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIIpamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIIpamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IISermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IISermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IISermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IISermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIThymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIAscorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIGlutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIAmino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIMethylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIMethylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IITrim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIVitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIMulti Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIVitamin 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 Hwy 19N, Palm Harbor FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIPrednisolone 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
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIPrednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIPrednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIPrednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIPrednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIPrednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
Lack of sterility assurance.
- 2019-02-20FDA-DrugPromise Pharmacy, LLCClass IIAcetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Lack of sterility assurance.
- 2019-02-13FDA-DrugNatures RxClass Ithe silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
- 2019-02-13FDA-DrugLupin Pharmaceuticals Inc.Class IIIBimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
- 2019-02-13FDA-DrugUS Pharmaceuticals Inc.Class IIMedline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
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