Class I · High risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
FDA Drug Recalls
2,661 recalls, newest first
Class III · Low risk Ongoing
Quelicin
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Class III · Low risk Ongoing
Normosol-M and 5% Dextrose
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class I · High risk Ongoing
Human Chorionic Gonadotropin
Reason Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class I · High risk Ongoing
APEXXX tablets
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Class I · High risk Ongoing
Vitamin Supplement
Reason Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Class II · Moderate risk Ongoing
Screenses Color Sunscreen
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Screenses Color Sunscreen Tinted facial make-up compact
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 50
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Women
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 50
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Salises Facial Moisturizing Acne Treatment Gel
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Antiperspirant Solution
Reason cGMP Deviations; product does not comply with cGMP requirements
Class III · Low risk Ongoing
Amidate
Reason Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Class I · High risk Ongoing
MIRACLE DIET 30 capsules
Reason Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
Class I · High risk Ongoing
MIRACLE ROCK 48 capsules
Reason Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Class II · Moderate risk Ongoing
1% Lidocaine HCl Injection
Reason Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Class I · High risk Ongoing
Akttive High Performance Fat Burner Gold dietary supplement capsules
Reason Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Class I · High risk Ongoing
Zero Xtreme High Performance Fat Burner capsules
Reason Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Class II · Moderate risk Ongoing
KETOROLAC Tromethamine Inj.
Reason Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk Ongoing
KETOROLAC Tromethamine Inj.
Reason Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk Ongoing
Ceftriaxone 1 gm/50 mL D5W
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.