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 →
FDA Recall
Terminated
Historical recordClass II
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.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
by Lannett Company, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
by ICU Medical Inc
- Reason
- Presence of Particulate Matter.
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
by ICU Medical Inc
- Reason
- Presence of Particulate Matter.
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.
by Sato Pharmaceutical Inc.
- Reason
- Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 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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