Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
CVS Health Children's Nasal Saline Drops with Himalayan Salt…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
CVS Health Children's Allergy Relief Liquid Medication…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
LA FRESH travel lite Sunnyside Lotion Wipe silky
Reason Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Class II · Moderate risk Terminated
Fungo Off Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Asma Stopper Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Anemia Off
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Appetrol Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Mental Tonic Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Thyro-Lo
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Smoke End Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Detensin
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Yeast Douche Powder
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Worm Off
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Vertigo Off Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Thyro-H
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Stone Purger Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Stomach Flu Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Sperm Booster
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Psoriasis Balm
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Prostatin Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Pain Stopper
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Pain Away
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.