🍔 Food 💊 Drugs 🏥 Medical Devices
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187 Class I

Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

SYNCHRONICITY SPA INC, DBA SUNTE 20240524 Ongoing
Distributed: Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
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Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01 Class II

Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Baxter Healthcare Corporation 20240617 Ongoing
Distributed: US Nationwide, Canada
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To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026 Class I

Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

Integrity Products 20240201 Ongoing
Distributed: Nationwide in the USA
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RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026 Class I

Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

Integrity Products 20240201 Ongoing
Distributed: Nationwide in the USA
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Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614 Class II

Reason: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 20240618 Terminated
Distributed: Nationwide. No foreign consignees.
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Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01. Class II

Reason: Presence of foreign substance.

Dr. Reddy's Laboratories, Inc. 20240607 Terminated
Distributed: IL, MS, OH
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Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40. Class II

Reason: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

SUN PHARMACEUTICAL INDUSTRIES INC 20240702 Ongoing
Distributed: Nationwide in the USA
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Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30 Class III

Reason: Failed Impurities/Degradation Specifications: Related Substances

Dr. Reddy's Laboratories, Inc. 20240604 Ongoing
Distributed: OH, MS
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Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308 Class III

Reason: Subpotent drug: out of specification results

Accord Healthcare, Inc. 20240618 Terminated
Distributed: USA Nationwide
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Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10 Class II

Reason: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Trigen Laboratories 20240617 Terminated
Distributed: Nationwide in the USA
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