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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

Matthew 7:25 Inc

Class I - Dangerous

Subpotent Drug

Mar 10, 2020 Compounded Drugs View Details →

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

Glaxosmithkline Consumer Healthcare Holdings

Class I - Dangerous

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Mar 16, 2020 Prescription Drugs View Details →

Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister

Glaxosmithkline Consumer Healthcare Holdings

Class I - Dangerous

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Mar 16, 2020 Prescription Drugs View Details →

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

Glaxosmithkline Consumer Healthcare Holdings

Class I - Dangerous

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Mar 16, 2020 Over-the-Counter View Details →

Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

Matthew 7:25 Inc

Class I - Dangerous

Subpotent Drug

Mar 10, 2020 Compounded Drugs View Details →

Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1

Grato Holdings

Class I - Dangerous

Labeling mix-up - Indications on product label are incorrect.

Nov 15, 2019 Other Drugs Nationwide View Details →

Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.

PAI Holdings, LLC.

Class I - Dangerous

SubPotent Drug: Low out-of-specification results for assay testing.

Mar 19, 2020 Prescription Drugs Nationwide View Details →

Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB

Glaxosmithkline Consumer Healthcare Holdings

Class I - Dangerous

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Mar 16, 2020 Other Drugs View Details →

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

Glaxosmithkline Consumer Healthcare Holdings

Class I - Dangerous

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Mar 16, 2020 Prescription Drugs View Details →

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

Perrigo Company PLC

Class I - Dangerous

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Oct 23, 2019 Prescription Drugs Nationwide View Details →

PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31

Par Pharmaceutical

Class I - Dangerous

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

Mar 4, 2020 Prescription Drugs Nationwide View Details →

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

Perrigo Company PLC

Class I - Dangerous

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Oct 23, 2019 Prescription Drugs Nationwide View Details →

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

Mylan Pharmaceuticals

Class I - Dangerous

Presence of particulate matter. presence of metal particles.

Mar 9, 2020 Prescription Drugs Nationwide View Details →

Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783

Med Man Distribution

Class I - Dangerous

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

Nov 8, 2019 Prescription Drugs Nationwide View Details →

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

Perrigo Company PLC

Class I - Dangerous

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Oct 23, 2019 Prescription Drugs Nationwide View Details →

Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3

Noven Therapeutics

Class I - Dangerous

Defective Delivery System: Out of specification for mechanical peel and shear.

Mar 2, 2020 Prescription Drugs Nationwide View Details →

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

Perrigo Company PLC

Class I - Dangerous

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Oct 23, 2019 Prescription Drugs Nationwide View Details →

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

Perrigo Company PLC

Class I - Dangerous

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Oct 23, 2019 Prescription Drugs Nationwide View Details →

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

Fresenius Medical Care Holdings

Class I - Dangerous

CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.

Mar 5, 2020 Prescription Drugs View Details →

Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.

Sun Pharmaceutical Industries

Class I - Dangerous

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

Mar 13, 2020 Prescription Drugs Nationwide View Details →