August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Herpes-P, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Deafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Bone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Awake, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Herbal Doctor Remedies recalls Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Hazard: CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
August 14, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-5
Hazard: GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
August 14, 2019DrugsFDA
AAA Pharmaceutical, Inc. recalls Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83
Hazard: Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
August 14, 2019DrugsFDA
American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-3
Hazard: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
August 7, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each bl
Hazard: Failed dissolution specifications : failed results at the 3-month stability time point.
August 7, 2019DrugsFDA
Piramal Critical Care, Inc. recalls Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Di
Hazard: Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
August 7, 2019DrugsFDA
LNK International, Inc. recalls Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distrib
Hazard: Microbial contamination of non-sterile product
August 7, 2019DrugsFDA
MAJOR PHARMACEUTICALS recalls DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr
Hazard: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
August 7, 2019DrugsFDA
American Health Packaging recalls Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: A
Hazard: Failed Dissolution Specifications: Out of specification result for the dissolution test.
August 7, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufa
Hazard: CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
August 7, 2019DrugsFDA
ImprimisRx NJ recalls Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ
Hazard: Subpotent Drug
August 7, 2019DrugsFDA
ImprimisRx NJ recalls Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 Wes
Hazard: Subpotent Drug
August 7, 2019DrugsFDA
Wise Pharmacy recalls Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded b
Hazard: Lack of Processing Controls
August 7, 2019DrugsFDA
Wise Pharmacy recalls Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy,
Hazard: Lack of Processing Controls
August 7, 2019DrugsFDA
Wise Pharmacy recalls Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy,
Hazard: Lack of Processing Controls
August 7, 2019DrugsFDA
Wise Pharmacy recalls Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy
Hazard: Lack of Processing Controls