Class I - Dangerous
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Sanofi-Aventis U.S.
Class I - Dangerous
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class I - Dangerous
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
Calvin Scott & Company
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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
cGMP Deviations.
Class I - Dangerous
Chemical Contamination: Product contains undeclared methanol.
Class I - Dangerous
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
cGMP Deviations.
Class I - Dangerous
Subpotent drug: Out of specification for assay at the 15-month test interval.