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