Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class I - Dangerous
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class I - Dangerous
Subpotent drug: Out of specification for assay at the 15-month test interval.
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30
Teva Pharmaceuticals USA
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
SCA Pharmaceuticals
Class I - Dangerous
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10
West-Ward Columbus
Class I - Dangerous
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class I - Dangerous
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class I - Dangerous
cGMP deviations
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50
Mylan Institutional
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Lupin Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).