Class III · Low risk
Ethacrynic Acid Tablets USP
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Doxycycline Hyclate Tablets USP
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Class II · Moderate risk
Sterile Curcumin 50mg/mL
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Curcumin
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
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
Potassium Acetate Injection
Short Fill
Class II · Moderate risk
Aloprim (allopurinol sodium)
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Class III · Low risk
Memantine Hydrochloride Extended-Release Capsules
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class III · Low risk
Esomeprazole Magnesium Delayed Release Capsules USP
Discoloration: product contains brown pellets
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
Infuvite PEDiatric Pharmacy
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
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 III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class II · Moderate risk
Lisinopril Tablets USP
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Class I · High risk
Ceftazidime for Injection USP and Dextrose for Injection USP
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Class I · High risk
KORE ORGANIC CBD Oil Watermelon 15mg*
Chemical Contamination; product contains elevated levels of lead
Class II · Moderate risk
Nizatidine Oral Solution
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.