Class II · Moderate risk Terminated
Progesterone 300 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
FDA Drug Recalls
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Class II · Moderate risk Terminated
Progesterone 150 mg Troche
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Progesterone
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Minoxidil/Biotin 1.25mg/5mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Formula 82M
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Formula 82F
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Finasteride Plus 1.25mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Estriol 8 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Estriol 6 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
D-Biotin 300 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Calcium citrate tetrahydrate USP powder
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class I · High risk Terminated
Lemon Blossom Hand Sanitizer
Reason Microbial contamination of non-sterile products: positive microbial contamination in product.
Class II · Moderate risk Terminated
Lidothol Patch
Reason CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class I · High risk Terminated
Mystic Shield PROTECTION
Reason Chemical Contamination: Presence of Undeclared Methanol
Class II · Moderate risk Terminated
Carbamazepine 200 mg Tablets
Reason FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Class II · Moderate risk Terminated
Cetrotide
Reason Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Class II · Moderate risk Terminated
Saniderm ADVANCED HAND SANITIZER
Reason CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Class I · High risk Terminated
Chlorhexidine Gluconate 0012 For Manufacturing
Reason Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Class I · High risk Terminated
All Clean Hand Sanitizer
Reason Chemical Contamination: Product contains undeclared methanol.
Class I · High risk Terminated
ChlroraPrep One-Step
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk Terminated
ChloraPrep With Tint
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk Terminated
BD ChloraPrep Clear 3 mL Applicators
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class III · Low risk Terminated
Tecfidera
Reason cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.