Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
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Other Drugs
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DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Homeocare Laboratories
Class I - Dangerous
cGMP deviations
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
Denison Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Denison Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Denison Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Denison Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I - Dangerous
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
Aurobindo Pharma USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class I - Dangerous
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.