Class II · Moderate risk
Systane
CGMP Deviations: products were stored outside the drug label specifications.
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Naphcon A eye drops
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Bisacodyl Suppositories
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Triple Antibiotic Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Testosterone Gel 1%
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations
Class II · Moderate risk
Hydrogen Peroxide Topical Solution USP
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Class II · Moderate risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
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
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.