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

Mar 26, 2020 Prescription Drugs Nationwide View Details →

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

PharMEDium Services

Class I - Dangerous

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Mar 16, 2020 Prescription Drugs Nationwide View Details →

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

PharMEDium Services

Class I - Dangerous

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Mar 16, 2020 Prescription Drugs Nationwide View Details →

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

Herbal Doctor Remedies

Class I - Dangerous

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

Mar 24, 2020 Prescription Drugs View Details →

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

Herbal Doctor Remedies

Class I - Dangerous

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

Mar 24, 2020 Prescription Drugs View Details →

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

Herbal Doctor Remedies

Class I - Dangerous

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

Mar 24, 2020 Prescription Drugs View Details →

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

PharMEDium Services

Class I - Dangerous

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Mar 16, 2020 Prescription Drugs Nationwide View Details →

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

Herbal Doctor Remedies

Class I - Dangerous

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

Mar 24, 2020 Prescription Drugs View Details →

Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

Avet Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Mar 23, 2020 Prescription Drugs Nationwide View Details →

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

PharMEDium Services

Class I - Dangerous

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Mar 16, 2020 Prescription Drugs Nationwide View Details →

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

Herbal Doctor Remedies

Class I - Dangerous

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

Mar 24, 2020 Prescription Drugs View Details →

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

Class I - Dangerous

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

Mar 25, 2020 Prescription Drugs View Details →

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

Class I - Dangerous

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

Mar 25, 2020 Prescription Drugs View Details →

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