JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
cGMP Deviations
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
CGMP violations.
Class I - Dangerous
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Tablet/Capsule Specifications
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
The Harvard Drug Group LLC
Class I - Dangerous
Failed Impurity/Degradation Specifications
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
The Harvard Drug Group LLC
Class I - Dangerous
Failed Impurity/Degradation Specifications
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class I - Dangerous
Lack of Sterility Assurance
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class I - Dangerous
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class I - Dangerous
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.