Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01
Wilshire Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class I - Dangerous
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class I - Dangerous
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I - Dangerous
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I - Dangerous
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I - Dangerous
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
Wilshire Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Impurity/Degradation Specifications
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211
Stanley Specialty Pharmacy Compounding and Wellness Center
Class I - Dangerous
Superpotent Drug. Lidocaine higher concentration than listed
Class I - Dangerous
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
Nostrum Laboratories
Class I - Dangerous
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
CGMP deviations.
Class I - Dangerous
Discoloration and failed pH specifications
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
Bausch Health Companies
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.