FDA Recall
TerminatedTerminated: February 16, 2021Historical recordClass III
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
by Strides Pharma Science Limited
- Reason
- Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass I
Chicago Indoor Garden, Inc.
- Product
- Mixed Greens 4 oz. Product contains red clover sprouts.
- Reason
- FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass I
Chicago Indoor Garden, Inc.
- Product
- Sprout Salad 6 oz. Product contains red clover sprouts.
- Reason
- FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass I
Chicago Indoor Garden, Inc.
- Product
- Spring Salad 6 oz. Product contains red clover sprouts.
- Reason
- FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass I
Chicago Indoor Garden, Inc.
- Product
- Red Clover 4 oz, Red Clover 2 Lbs. Products have Red Clover…
- Reason
- FDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firm's sprouts with an outbreak of E. coli.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Moonstruck Chocolate Company
- Product
- Moonstruck Praline Pecan & Ginger Element Bar in Dark Chocol…
- Reason
- Undeclared milk.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 25, 2021Historical recordClass II
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
- Published
- March 18, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 25, 2021Historical recordClass III
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
- Published
- March 18, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 31, 2022Historical recordClass II
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
by Redline Pharmacy Solutions
- Reason
- Lack Of Processing Controls
- Published
- March 18, 2020
- Distribution
- Sold to patients in Nebraska
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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