Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
CGMP DEVIATIONS
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Amerisource Health Services
Class I - Dangerous
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Sciegen Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
Volt Candy Wholesale Club
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: Potential product carryover.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.