FDA Recall
Terminated
Historical recordClass 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
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by CareFusion 213, LLC
- Reason
- Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
- Published
- August 26, 2020
- Distribution
- Puerto Rico, Guam, United Arab Emirates,…
View recall →
FDA Recall
Terminated
Historical recordClass 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
by CareFusion 213, LLC
- Reason
- Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
- Published
- August 26, 2020
- Distribution
- Puerto Rico, Guam, United Arab Emirates,…
View recall →
FDA Recall
Terminated
Historical recordClass 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
by CareFusion 213, LLC
- Reason
- Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
- Published
- August 26, 2020
- Distribution
- Puerto Rico, Guam, United Arab Emirates,…
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Lannett Company, Inc.
- Reason
- Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass 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
by Sanofi-Aventis U.S. LLC
- Reason
- Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Ferring Pharmaceuticals Inc
- Reason
- Superpotent Drug
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Ferring Pharmaceuticals Inc
- Reason
- Superpotent Drug
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Ferring Pharmaceuticals Inc
- Reason
- Superpotent Drug
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Itech 361 LLC
- Reason
- Chemical Contamination: Product contains undeclared methanol.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass 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
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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