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Showing 6,961–6,980 of 17,964 drug recalls
Drug RecallTerminatedHistorical 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.
Recall initiated
October 15, 2019
Reported by FDA
November 20, 2019
Distribution
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
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
Recall initiated
October 1, 2019
Reported by FDA
November 20, 2019
Distribution
Nationwide within the United States, Guam and Saipan
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
Recall initiated
October 1, 2019
Reported by FDA
November 20, 2019
Distribution
Nationwide within the United States, Guam and Saipan
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
Recall initiated
October 1, 2019
Reported by FDA
November 20, 2019
Distribution
Nationwide within the United States, Guam and Saipan
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
Recall initiated
October 1, 2019
Reported by FDA
November 20, 2019
Distribution
Nationwide within the United States, Guam and Saipan
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).
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).
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.
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.
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.
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
by Novitium Pharma LLC
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
by Golden State Medical Supply Inc.
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
by Golden State Medical Supply Inc.
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
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.
Read the full medical disclaimer.
