CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent
Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent
scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1
Real Clean Distribuciones SA de CV
Class I - Dangerous
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I - Dangerous
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class I - Dangerous
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class I - Dangerous
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
Edge Pharma
Class I - Dangerous
Labeling: Label Error on Declared Strength
Class I - Dangerous
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
Teva Pharmaceuticals USA
Class I - Dangerous
Sub-Potent Drug: Out of specification test results for potency (below specification).
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
Maquiladora Miniara Sa De Cv
Class I - Dangerous
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220
Santa Cruz Biotechnology
Class I - Dangerous
Subpotent drug
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Chemical Contamination: Product contains methanol.
Class I - Dangerous
Labeling: Error on Declared Strength
Class I - Dangerous
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I - Dangerous
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.