Class III · Low risk
Hydromorphone HCL PF
Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Mojo Max Fusion XXX
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Class II · Moderate risk
Fasenra (benralizumab)
Lack of Assurance of Sterility:
Class II · Moderate risk
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk
Carbidopa
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Tavaborole Topical solution 5%
Discoloration
Class II · Moderate risk
Testo-100 Ciii
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II · Moderate risk
Zicam" Medicated Fruit Drops Elderberry Flavor
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk
Medline
Subpotent Drug
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II · Moderate risk
Afco
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II · Moderate risk
Wyandotte
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Aloe Up Sport Performance Sunscreen Lotion SPF 30
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity