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.

2020-04-15FDA-DrugHerbal Doctor RemediesClass II
DeTensin Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Dermatoxin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Dermamycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
De-Fibroidin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Cellulite Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Blood Clot Purger, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Asthma Chest Rub, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Asma Stopper, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Age Stop Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Age Back, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugHerbal Doctor RemediesClass II
Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
2020-04-15FDA-DrugAvet Pharmaceuticals, Inc.Class II
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
2020-04-15FDA-DrugAvet Pharmaceuticals, Inc.Class II
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
2020-04-15FDA-DrugTeva Pharmaceuticals USAClass II
LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
2020-04-15FDA-DrugTeva Pharmaceuticals USAClass II
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
2020-04-15FDA-DrugTeva Pharmaceuticals USAClass II
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
2020-04-15FDA-DrugInnovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyClass II
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Lack of Assurance of Sterility
2020-04-15FDA-DrugInnovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyClass II
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Lack of Assurance of Sterility
2020-04-15FDA-DrugInnovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyClass II
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Lack of Assurance of Sterility
2020-04-15FDA-DrugInnovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyClass II
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Lack of Assurance of Sterility
2020-04-15FDA-DrugInnovative Intrathecal Solutions, Inc. dba Innovative Compounding PharmacyClass II
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Lack of Assurance of Sterility
2020-04-15FDA-DrugPharMEDium Services, LLCClass II
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
2020-04-15FDA-DrugPharMEDium Services, LLCClass II
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
2020-04-15FDA-DrugPharMEDium Services, LLCClass II
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
2020-04-15FDA-DrugPharMEDium Services, LLCClass II
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
2020-04-15FDA-DrugPharMEDium Services, LLCClass II
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
2020-04-15FDA-DrugPharMEDium Services, LLCClass II
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
Firm is recalling 46 lots of various products because of a lack of sterility assurance.

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