Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
All Recalls
95,025 total recalls in our database
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
Ferring Pharmaceuticals
Superpotent Drug
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
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.
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
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
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
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
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
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
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Olympus Corporation of the Americas
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.