Class I - Dangerous
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
Albek De Mexico S.A. De C.V.
Class I - Dangerous
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I - Dangerous
Labeling: Product Contains Undeclared API; Incorrect formulation
DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Failed Dissolution Specifications: Out of specification for dissolution.
Class I - Dangerous
GMP Deviations
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Class I - Dangerous
GMP Deviations
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
Milbar Laboratories
Class I - Dangerous
GMP Deviations
DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6
Albek De Mexico S.A. De C.V.
Class I - Dangerous
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I - Dangerous
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories
Class I - Dangerous
GMP Deviations
DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
Milbar Laboratories
Class I - Dangerous
GMP Deviations
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
Albek De Mexico S.A. De C.V.
Class I - Dangerous
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Class I - Dangerous
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class I - Dangerous
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
Albek De Mexico S.A. De C.V.
Class I - Dangerous
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.