Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
FDA Drug Recalls
268 recalls, newest first
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class II · Moderate risk
PrednisoLONE Oral Solution USP
Defective Container: Product has incomplete induction seals.
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Class II · Moderate risk
VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Refenesen Mucus Relief Tablet 30 Ct Sku 917531 Mucinex Dm Max…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dayquil Cold Flu Lqd 12 Fl Oz Sku 900205 Ric Night Time Cld Flu…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Robitussin Cough N Chest Congestion 4 Fl Oz Sku 919471 Delsym…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Ready in Case Ctrzne Alrgy All Dy Tblt 5 Ct Sku 900448 Zyrtec…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Claritin Allergy Liq Chldrns Grape 2 Floz Sku 900834 Claritin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Qp Dphnhdrme Alrgy Min Tblt 12 Ct Sku 900449 Qp Allergy…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Gs Anti Diarrheal Loperamide Caplet 12 Ct Sku 915632 Imodium Ad…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Guardian Bismuth Chwble Chry Tabs 30 Ctsku 902321 Ric Bismuth…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.