Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
FDA Drug Recalls
381 recalls, newest first
Class II · Moderate risk
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Sucralfate Tablets
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk
Shave and Skincare Power Stick Original Nourishing Invisible…
CGMP Deviations
Class II · Moderate risk
Beauty & Skincare Power Stick original nourishing invisible…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Peripheral Parenteral Nutrition
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class II · Moderate risk
temper tamer
CGMP Deviations
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
cGMP Deviations
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk
Kapsin Ointment
CGMP Deviations
Class II · Moderate risk
Hemopropin Ointment
CGMP Deviations
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Cetirizine Hydrochloride Tablets
CGMP Deviations
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations