🍔 Food 💊 Drugs 🏥 Medical Devices
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02 Class III

Reason: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Akorn, Inc. 20230130 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. Class II

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Urban Electric Power 20230117 Terminated
Distributed: Nationwide within the United States
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Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles Class II

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Urban Electric Power 20230117 Terminated
Distributed: Nationwide within the United States
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Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81 Class II

Reason: Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

SUN PHARMACEUTICAL INDUSTRIES INC 20230113 Terminated
Distributed: Nationwide in the U.S.
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Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland Class II

Reason: CGMP deviations

DISCOVERY PHARMA LLC 20221109 Terminated
Distributed: CA, FL, WA
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Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2 Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976 Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976 Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7 Class II

Reason: cGMP Deviations

Frenda Corporation 20221215 Terminated
Distributed: Puerto Rico
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