Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
D-0231-2024January 24, 2024Texarkana, TX
Pharma Nobis LLC
Class IIOngoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
D-0229-2024January 24, 2024Texarkana, TX
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Class ICompleted
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made...
Reason: Chemical Contamination: presence of benzene
D-0236-2024January 24, 2024Tarrytown, NY
Seaway Pharma Inc.
Class IIOngoing
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI...
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
D-0217-2024January 10, 2024Massena, NY
Seaway Pharma Inc.
Class IIOngoing
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 6386...
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
D-0214-2024January 10, 2024Massena, NY
Seaway Pharma Inc.
Class IIOngoing
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancas...
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
D-0215-2024January 10, 2024Massena, NY
Seaway Pharma Inc.
Class IIOngoing
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, M...
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
D-0216-2024January 10, 2024Massena, NY
TCP HRB ACQUISITON LLC
Class IOngoing
Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070...
Reason: Chemical contamination: Presence of benzene
D-0207-2024January 3, 2024Westport, CT
TCP HRB ACQUISITON LLC
Class IOngoing
Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06
Reason: Chemical contamination: Presence of benzene
D-0208-2024January 3, 2024Westport, CT
TCP HRB ACQUISITON LLC
Class IOngoing
Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06
Reason: Chemical contamination: Presence of benzene
D-0209-2024January 3, 2024Westport, CT
Blistex Inc
Class ITerminated
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex...
Reason: Chemical contamination: Presence of benzene
D-0159-2024December 27, 2023Oak Brook, IL
Insight Pharmaceuticals Corporation
Class ICompleted
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY...
Reason: Chemical Contamination; presence of benzene.