Drug Recall
Ongoing
Historical recordClass II
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
by Par Sterile Products LLC
- Reason
- Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
- Recall initiated
- January 11, 2024
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA
View recall →
Drug Recall
Ongoing
Historical recordClass II
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.
by Pharma Nobis LLC
- Reason
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Recall initiated
- December 21, 2023
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide.
View recall →
Drug Recall
Ongoing
Historical recordClass II
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
by Pharma Nobis LLC
- Reason
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Recall initiated
- December 21, 2023
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
by Pharma Nobis LLC
- Reason
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Recall initiated
- December 21, 2023
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 Topical spray cans, each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Dist. by: Procter & Gamble, Cincinnati, OH 45202,
by The Procter & Gamble Company
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass II
Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9
by The Procter & Gamble Company
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass II
Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7
by The Procter & Gamble Company
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass II
Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz (532 mL), 2-in-1 Shampoo & Conditioner 13.5 Fl Oz (400 mL), and Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g). Dist. by: Procter & Gamble, Cincinnati, OH 45202. Gift Set NDC 69423-590-01, UPC 12044 04853 5
by The Procter & Gamble Company
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass II
Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-478-10, UPC 0 37000 74772 7
by The Procter & Gamble Company
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass II
Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely Clean, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-384-10, UPC 0 37000 74764 2
by The Procter & Gamble Company
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass I
Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0
by The Procter & Gamble Company
- Reason
- Chemical contamination: presence of benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Terminated
Historical recordClass I
Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Distr. by: Procter & Gamble, Cincinnati, OH 45202
by The Procter & Gamble Company
- Reason
- Chemical contamination: presence of benzene
- Recall initiated
- November 23, 2021
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
View recall →
Drug Recall
Ongoing
Historical recordClass I
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
by Pfizer Inc.
- Reason
- Presence of Particulate Matter; identified as glass
- Recall initiated
- December 21, 2023
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide in the USA and Puerto Rico.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.
by Pharma Nobis LLC
- Reason
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Recall initiated
- December 21, 2023
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide.
View recall →
Drug Recall
Ongoing
Historical recordClass II
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC 46122-741-38
by Pharma Nobis LLC
- Reason
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Recall initiated
- December 21, 2023
- Reported by FDA
- January 24, 2024
- Distribution
- Nationwide.
View recall →
Drug Recall
Completed
Historical recordClass II
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
- Recall initiated
- January 2, 2024
- Reported by FDA
- January 17, 2024
- Distribution
- USA Nationwide
View recall →
Drug Recall
Ongoing
Historical recordClass II
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
by Rising Pharma Holding, Inc.
- Reason
- Presence of Foreign Tablets/Capsules
- Recall initiated
- December 29, 2023
- Reported by FDA
- January 17, 2024
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- Recall initiated
- December 20, 2023
- Reported by FDA
- January 17, 2024
- Distribution
- Product was distributed nationwide.
View recall →
Drug Recall
Completed
Historical recordClass I
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
by InvaGen Pharmaceuticals, Inc.
- Reason
- Defective Container: powder may leak out of the pouch
- Recall initiated
- November 17, 2023
- Reported by FDA
- January 17, 2024
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- Recall initiated
- December 15, 2023
- Reported by FDA
- January 17, 2024
- Distribution
- US Nationwide.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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