Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
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Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Protz real protection Antibacterial Hand Sanitizer
Reason Lack of CGMPs:
Class II · Moderate risk Terminated
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz
Reason Lack of CGMPs:
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk Terminated
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP
Reason CGMP Deviations
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class I · High risk Terminated
Goldenseal Root Powder Organic
Reason Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Class I · High risk Terminated
Tranexamic Acid Injection
Reason 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 · High risk Terminated
Amiodarone Hydrochloride Injection
Reason 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 · High risk Terminated
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug