August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquer
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquer
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerq
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: C
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerq
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: S
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Ma
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactur
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Ultra Seal Corporation recalls Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactu
Hazard: Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
August 26, 2020DrugsFDA
Ultra Seal Corporation recalls Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufac
Hazard: Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
August 26, 2020DrugsFDA
CareFusion 213, LLC recalls ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear,
Hazard: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
August 26, 2020DrugsFDA
CareFusion 213, LLC recalls ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Li
Hazard: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
August 26, 2020DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile
Hazard: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
August 26, 2020DrugsFDA
Lannett Company, Inc. recalls Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Ma
Hazard: Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
August 26, 2020DrugsFDA
Sanofi-Aventis U.S. LLC recalls Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC
Hazard: Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
August 26, 2020DrugsFDA
Ferring Pharmaceuticals Inc recalls STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Be
Hazard: Superpotent Drug
August 26, 2020DrugsFDA
Ferring Pharmaceuticals Inc recalls Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMAC
Hazard: Superpotent Drug
August 26, 2020DrugsFDA
Ferring Pharmaceuticals Inc recalls DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Pa
Hazard: Superpotent Drug
August 19, 2020DrugsFDA
Itech 361 LLC recalls All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico
Hazard: Chemical Contamination: Product contains undeclared methanol.
August 19, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/7
Hazard: Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
August 19, 2020DrugsFDA
Eosera, Inc. recalls Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensi
Hazard: cGMP Deviations.