Class III · Low risk
Olmesartan Medoxomil Tablets
Presence of Foreign Tablet/Capsule
FDA Drug Recalls
638 recalls, newest first
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class II · Moderate risk
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Presence of particulate matter in solution - black and transparent particles
Class III · Low risk
Metformin Hydrochloride Tablets USP
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk
Hand Sanitizer
Discoloration and Presence of Foreign Substance
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class I · High risk
Daptomycin for Injection
Presence of Particulate Matter
Class II · Moderate risk
Clozapine Tablets USP tablet
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Moderate risk
Unasyn (ampicillin sodium/sulbacatam)
Presence of Particulate Matter: particulate matter identified after reconstitution.
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Class III · Low risk
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac)
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Estradiol
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Class III · Low risk
Tacrolimus Capsules
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.