Class II · Moderate risk Terminated
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA…
Reason cGMP Deviations
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Class II · Moderate risk Ongoing
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches…
Reason Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II · Moderate risk Ongoing
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter…
Reason Labeling: Missing Label
Class III · Low risk Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona…
Reason Crystallization
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad…
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Terminated
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA…
Reason Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class II · Moderate risk Terminated
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel…
Reason cGMP Deviations
Class II · Moderate risk Terminated
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006…
Reason cGMP Deviations
Class II · Moderate risk Terminated
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC…
Reason cGMP Deviations
Class II · Moderate risk Terminated
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099…
Reason cGMP Deviations
Class II · Moderate risk Terminated
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%…
Reason cGMP Deviations
Class II · Moderate risk Terminated
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC…
Reason cGMP Deviations
Class II · Moderate risk Terminated
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031…
Reason cGMP Deviations
Class II · Moderate risk Terminated
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches…
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches…
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402…
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02)…
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Terminated
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02)…
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Terminated
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02)…
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834…
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC…
Reason Failed Impurities/Degradation Specification