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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 5981–6000 of 17,773 recalls

Class IITerminated

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

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Lack of Assurance of Sterility

March 26, 2020 · DrugView details →
Class IITerminated

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

Avet Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

March 26, 2020 · Drug
View details →
Class IITerminated

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

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Lack of Assurance of Sterility

March 26, 2020 · DrugView details →
Class IITerminated

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

Avet Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

March 26, 2020 · DrugView details →
Class IITerminated

Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Lack of Assurance of Sterility

March 26, 2020 · DrugView details →
Class IITerminated

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

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Lack of Assurance of Sterility

March 26, 2020 · DrugView details →
Class IITerminated

Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Lack of Assurance of Sterility

March 26, 2020 · DrugView details →
Class IIOngoing

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

Teva Pharmaceuticals USA

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

March 25, 2020 · DrugView details →
Class IIOngoing

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

Teva Pharmaceuticals USA

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

March 25, 2020 · DrugView details →
Class IIOngoing

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

Teva Pharmaceuticals USA

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

March 25, 2020 · DrugView details →
Class IIITerminated

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02

Akorn Inc

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

March 25, 2020 · DrugView details →
Class IITerminated

Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Detoxin-S, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Herpes-G, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Dermatoxin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Phlegm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Tution 130, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
Class IITerminated

Pain Away, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

March 24, 2020 · DrugView details →
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