September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, p
Hazard: Microbial Contamination of Non-Sterile Products.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups pe
Hazard: Microbial Contamination of Non-Sterile Products.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: Microbial Contamination of Non-Sterile Products.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: Microbial Contamination of Non-Sterile Products
September 7, 2022DrugsFDA
Padagis US LLC recalls Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Pe
Hazard: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
September 7, 2022DrugsFDA
Tsm Brands LLC recalls Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands
Hazard: Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
September 7, 2022DrugsFDA
Tsm Brands LLC recalls Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 0
Hazard: Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
September 7, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North W
Hazard: CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
September 7, 2022DrugsFDA
LNK International, Inc. recalls Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmac
Hazard: Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
September 7, 2022DrugsFDA
Akorn, Inc recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn
Hazard: Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
September 7, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate
Hazard: cGMP deviation: Product held outside of appropriate temperature storage conditions.
September 7, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 4
Hazard: cGMP deviation: Product held outside of appropriate temperature storage conditions.
September 7, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1.
Hazard: cGMP deviation: Product held outside of appropriate temperature storage conditions.
September 7, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist
Hazard: cGMP deviation: Product held outside of appropriate temperature storage conditions.
September 7, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (
Hazard: cGMP deviation: Product held outside of appropriate temperature storage conditions.
September 7, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ.
Hazard: cGMP deviation: Product held outside of appropriate temperature storage conditions.
August 31, 2022DrugsFDA
Midlab Incorporated recalls Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottl
Hazard: CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
August 31, 2022DrugsFDA
Midlab Incorporated recalls Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61
Hazard: CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHR
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Famil
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.
August 31, 2022DrugsFDA
Family Dollar Stores, Llc. recalls READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY C
Hazard: CGMP Deviations: product held outside appropriate storage temperature conditions.