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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004

Little Moon Essentials

Class I - Dangerous

CGMP deviations

Jun 20, 2024 Other Drugs Nationwide View Details →

Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004

Little Moon Essentials

Class I - Dangerous

CGMP deviations

Jun 20, 2024 Other Drugs Nationwide View Details →

Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004

Little Moon Essentials

Class I - Dangerous

CGMP deviations

Jun 20, 2024 Other Drugs Nationwide View Details →

RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

Integrity Products

Class I - Dangerous

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

Feb 1, 2024 Prescription Drugs Nationwide View Details →

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Impurities/Degradation Specifications: Related Substances

Jun 4, 2024 Prescription Drugs View Details →

To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

Integrity Products

Class I - Dangerous

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

Feb 1, 2024 Prescription Drugs Nationwide View Details →

Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004

Little Moon Essentials

Class I - Dangerous

CGMP deviations

Jun 20, 2024 Other Drugs Nationwide View Details →

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01

PACIRA PHARMACEUTICALS

Class I - Dangerous

Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C

Jun 12, 2024 Prescription Drugs Nationwide View Details →

Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24

Pfizer

Class I - Dangerous

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

May 20, 2024 Prescription Drugs Nationwide View Details →

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03

Pfizer

Class I - Dangerous

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

May 20, 2024 Prescription Drugs Nationwide View Details →

Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606

Contract Pharmacal

Class I - Dangerous

Discoloration: Brownish tablets

May 20, 2024 Prescription Drugs View Details →

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

Golden State Medical Supply

Class I - Dangerous

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

May 13, 2024 Prescription Drugs Nationwide View Details →

Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.

Coast Quality Pharmacy, LLC

Class I - Dangerous

Presence of Foreign Substance; Broken metal piece found embedded in tablet.

Apr 24, 2024 Prescription Drugs Nationwide View Details →

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

Neilmed Pharmaceuticals

Class I - Dangerous

Sub-potent Drug

Jun 24, 2024 Other Drugs Nationwide View Details →

OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370

MexHealth

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

May 22, 2024 Prescription Drugs Nationwide View Details →

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

Lupin Pharmaceuticals

Class I - Dangerous

Failed Content Uniformity Specifications

May 30, 2024 Prescription Drugs Nationwide View Details →

Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30

Eugia US

Class I - Dangerous

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

May 23, 2024 Prescription Drugs Nationwide View Details →

Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0

Consumer Product Partners

Class I - Dangerous

Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile

May 28, 2024 Other Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

May 17, 2024 Prescription Drugs Nationwide View Details →

Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02

Denison Pharmaceuticals

Class I - Dangerous

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

May 28, 2024 Other Drugs View Details →