Class II · Moderate risk Terminated
Launch Sequence Capsules
Reason Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Divalproex Sodium Delayed-Release Tablets
Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk Terminated
Hydrogen Peroxide Topical Solution
Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
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.
Class II · Moderate risk Ongoing
Guardian Bismuth Chwble Chry Tabs 30 Ctsku 902321 Ric Bismuth…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.