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Over-the-Counter

💊 Drugs • 320 recalls

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.

Wuhan Bingbing Pharmaceutical Co.

Class I - Dangerous

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

May 19, 2020 Over-the-Counter Nationwide 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 →

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

Efficient Laboratories

Class I - Dangerous

Microbial Contamination of Non-Sterile Products

Jan 31, 2020 Over-the-Counter Nationwide View Details →

Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13

Altaire Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility

Jul 2, 2019 Over-the-Counter Nationwide View Details →

Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15

Altaire Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility

Jul 2, 2019 Over-the-Counter Nationwide View Details →

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Aug 9, 2019 Over-the-Counter Nationwide View Details →

Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties

Class I - Dangerous

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Aug 9, 2019 Over-the-Counter Nationwide View Details →

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Aug 9, 2019 Over-the-Counter Nationwide View Details →

Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties

Class I - Dangerous

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Aug 9, 2019 Over-the-Counter Nationwide View Details →

Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties

Class I - Dangerous

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Aug 9, 2019 Over-the-Counter Nationwide View Details →

Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Ridge Properties

Class I - Dangerous

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Aug 9, 2019 Over-the-Counter Nationwide View Details →

CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2

US Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Jul 11, 2019 Over-the-Counter Nationwide View Details →

CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6

US Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Jul 11, 2019 Over-the-Counter Nationwide View Details →

Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.

US Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Jul 11, 2019 Over-the-Counter Nationwide View Details →

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010

Unipharma

Class I - Dangerous

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Jul 15, 2019 Over-the-Counter Nationwide View Details →

DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

NingBo Huize Commodity Co.,Ltd.

Class I - Dangerous

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Apr 1, 2019 Over-the-Counter View Details →

TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

NingBo Huize Commodity Co.,Ltd.

Class I - Dangerous

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Apr 1, 2019 Over-the-Counter View Details →

ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

NingBo Huize Commodity Co.,Ltd.

Class I - Dangerous

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Apr 1, 2019 Over-the-Counter View Details →

ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

NingBo Huize Commodity Co.,Ltd.

Class I - Dangerous

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Apr 1, 2019 Over-the-Counter View Details →

TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

NingBo Huize Commodity Co.,Ltd.

Class I - Dangerous

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Apr 1, 2019 Over-the-Counter View Details →

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