🍔 Food 💊 Drugs 🏥 Medical Devices
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01 Class III

Reason: Failed Impurities/Degradation Specifications

Glenmark Pharmaceuticals Inc., USA 20231020 Terminated
Distributed: Nationwide in the USA
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Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88 Class II

Reason: Failed Impurities/Degradation Specifications.

SUN PHARMACEUTICAL INDUSTRIES INC 20231020 Terminated
Distributed: Nationwide within the United States
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Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88 Class II

Reason: Failed Impurities/Degradation Specifications.

SUN PHARMACEUTICAL INDUSTRIES INC 20231020 Terminated
Distributed: Nationwide within the United States
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Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15 Class II

Reason: CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

Safecor Health, LLC 20231019 Terminated
Distributed: Distributed Nationwide in the USA
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Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01 Class II

Reason: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Padagis US LLC 20230928 Ongoing
Distributed: Nationwide within the United States
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Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01 Class III

Reason: Subpotent Drug

Edenbridge Pharmaceuticals, LLC 20231020 Terminated
Distributed: Nationwide within the United States
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TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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