Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
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Over-the-Counter
💊 Drugs • 328 recalls
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I - Dangerous
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Class I - Dangerous
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Class I - Dangerous
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Presence of foreign substance: glass particle
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class I - Dangerous
Lack of assurance of sterility
Class I - Dangerous
Lack of assurance of sterility
Class I - Dangerous
Lack of assurance of sterility
Class I - Dangerous
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Subpotent Drug
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Class I - Dangerous
Labeling; Product Contains Undeclared API (Oxybenzone)
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Class I - Dangerous
Labeling: Label Mix-Up