Drug and pharmaceutical recalls

17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
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
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugUltra Seal CorporationClass III
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
2020-08-26FDA-DrugUltra Seal CorporationClass III
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
2020-08-26FDA-DrugCareFusion 213, LLCClass I
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2020-08-26FDA-DrugCareFusion 213, LLCClass I
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2020-08-26FDA-DrugCareFusion 213, LLCClass I
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2020-08-26FDA-DrugLannett Company, Inc.Class II
Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
2020-08-26FDA-DrugSanofi-Aventis U.S. LLCClass II
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
2020-08-26FDA-DrugFerring Pharmaceuticals IncClass I
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
Superpotent Drug
2020-08-26FDA-DrugFerring Pharmaceuticals IncClass I
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
Superpotent Drug
2020-08-26FDA-DrugFerring Pharmaceuticals IncClass I
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
Superpotent Drug
2020-08-19FDA-DrugItech 361 LLCClass I
All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0
Chemical Contamination: Product contains undeclared methanol.
2020-08-19FDA-DrugLupin Pharmaceuticals Inc.Class II
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
2020-08-19FDA-DrugEosera, Inc.Class II
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5
cGMP Deviations.
2020-08-19FDA-DrugEosera, Inc.Class II
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
cGMP Deviations.
2020-08-19FDA-DrugEosera, Inc.Class II
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
cGMP Deviations.
2020-08-19FDA-DrugEosera, Inc.Class II
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
cGMP Deviations.
2020-08-19FDA-DrugGolden State Medical Supply Inc.Class III
Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
2020-08-19FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class III
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
2020-08-19FDA-DrugSCA PharmaceuticalsClass II
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
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
2020-08-19FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Subpotent drug: Out of specification for assay at the 15-month test interval.
2020-08-19FDA-DrugTeva Pharmaceuticals USAClass II
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
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
2020-08-19FDA-DrugWest-Ward Columbus IncClass III
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
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
2020-08-12FDA-DrugSpartan Chemical Co IncClass I
Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.
Microbial contamination of non-sterile products: positive microbial contamination in product.

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