September 15, 2021DrugsFDA
Charles Paint Research Inc recalls HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6
Hazard: CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
September 8, 2021DrugsFDA
China Gel Inc recalls aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 8780
Hazard: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
September 8, 2021DrugsFDA
China Gel Inc recalls CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13
Hazard: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
September 8, 2021DrugsFDA
China Gel Inc recalls CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13;
Hazard: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
September 8, 2021DrugsFDA
Macleods Pharma Usa Inc recalls Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ
Hazard: Presence of foreign matter
September 8, 2021DrugsFDA
Akorn, Inc. recalls Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, In
Hazard: Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
September 8, 2021DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New
Hazard: Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
September 8, 2021DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by:
Hazard: Subpotent
September 8, 2021DrugsFDA
Global Sanitizers LLC recalls MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactur
Hazard: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
September 8, 2021DrugsFDA
Global Sanitizers LLC recalls MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in
Hazard: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
September 8, 2021DrugsFDA
Global Sanitizers LLC recalls MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in
Hazard: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
September 8, 2021DrugsFDA
Global Sanitizers LLC recalls MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactur
Hazard: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
September 8, 2021DrugsFDA
Global Sanitizers LLC recalls MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufa
Hazard: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
September 8, 2021DrugsFDA
Global Sanitizers LLC recalls MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactur
Hazard: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
September 8, 2021DrugsFDA
Granules USA, Inc. recalls Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A,
Hazard: CGMP Deviations
September 8, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laborator
Hazard: CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
September 8, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratori
Hazard: CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
September 8, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratori
Hazard: CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
September 1, 2021DrugsFDA
Eli Lilly & Company recalls Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46
Hazard: Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
September 1, 2021DrugsFDA
KVK-Tech, Inc. recalls Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 1
Hazard: Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
September 1, 2021DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie G
Hazard: Labeling: Not elsewhere classified: Mislabeling
September 1, 2021DrugsFDA
HIS ENTERPRISE INC recalls Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Hazard: Marketed without ANDA/NDA approval
September 1, 2021DrugsFDA
Teligent Pharma, Inc. recalls Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Hazard: Defective container: possibility for lack of seal integrity.
September 1, 2021DrugsFDA
SterRx, LLC recalls Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141
Hazard: Lack of Assurance of Sterility
September 1, 2021DrugsFDA
SterRx, LLC recalls Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141
Hazard: Non-Sterility: firm's third party lab confirmed microbial contamination.
September 1, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-1
Hazard: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
September 1, 2021DrugsFDA
Custopharm, Inc. recalls FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceutical
Hazard: Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10
Hazard: SubPotent: Out of Specification
September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangebu
Hazard: SubPotent: Out of Specification
September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangebur
Hazard: SubPotent: Out of Specification