Class I - Dangerous
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class I - Dangerous
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Zyla Life Sciences US
Class I - Dangerous
Sub-potent Drug: Lower potency than labeled.
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Dissolution Specifications: Out of specification for dissolution.
Class I - Dangerous
Presence of Particulate Matter: identified as glass.
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
GlaxoSmithKline Consumer Healthcare Holdings
Class I - Dangerous
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
GlaxoSmithKline Consumer Healthcare Holdings
Class I - Dangerous
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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
GlaxoSmithKline Consumer Healthcare Holdings
Class I - Dangerous
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Impurities/Degradation Specifications
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
GlaxoSmithKline Consumer Healthcare Holdings
Class I - Dangerous
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class I - Dangerous
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
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
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Class I - Dangerous
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
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
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Impurities/Degradation Specifications.
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
GlaxoSmithKline Consumer Healthcare Holdings
Class I - Dangerous
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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
GlaxoSmithKline Consumer Healthcare Holdings
Class I - Dangerous
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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
Edenbridge Pharmaceuticals
Class I - Dangerous
Subpotent Drug