Class II · Moderate risk Completed
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
FDA Drug Recalls
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Class II · Moderate risk Completed
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx…
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA…
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA…
Reason cGMP deviations
Class II · Moderate risk Completed
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis…
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk Completed
Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN…
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk Completed
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC…
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk Completed
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I · High risk Completed
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per…
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Completed
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Completed
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC…
Reason Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk Completed
AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with…
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk Completed
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx…
Reason Temperature Abuse; temperature excursion during shipping
Class I · High risk Completed
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC…
Reason Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk Completed
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ…
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473…
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For…
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I · High risk Completed
X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class II · Moderate risk Completed
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham…
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Completed
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE…
Reason Cross contamination: the excipient was found to be contaminated with theophylline.
Class I · High risk Completed
Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02…
Reason Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.