Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Drugs Recalls
Prescription and over-the-counter medications
Fungo Lotion, 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
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
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
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
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Pain Stopper, 500mg Capsules, 90-count bottle, 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
Vitiligo Off Ointment, 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
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.
Vertigo 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
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.
New Life, 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
Skin Lift Balm, 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
De-Fibroidin, 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
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
PharMEDium Services
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Max Slim, 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
Hair Back Lotion, 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
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
PharMEDium Services
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Detoxin Ex, 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
Herpes 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
Hair Back Ex, 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
Purple Gold Balm, 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