FDA Recall
Terminated
Historical recordClass II
Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.
by 8046255 Canada Inc. DBA Viatrexx
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
by Sato Pharmaceutical Inc.
- Reason
- Subpotent Drug
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501,
by Sato Pharmaceutical Inc.
- Reason
- Subpotent Drug
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535
by Sato Pharmaceutical Inc.
- Reason
- Subpotent Drug
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603
by Sato Pharmaceutical Inc.
- Reason
- Subpotent Drug
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
by Apotex Inc.
- Reason
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
by Apotex Inc.
- Reason
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
by Apotex Inc.
- Reason
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
by Apotex Inc.
- Reason
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
by Apotex Inc.
- Reason
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
by Apotex Inc.
- Reason
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
by Novitium Pharma LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
by Novitium Pharma LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
by Novitium Pharma LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- November 20, 2019
- 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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