Class I · High risk Terminated
LACTATED RINGER'S Injection
Reason Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Potassium Acetate Injection
Reason Short Fill
Class II · Moderate risk Terminated
Aloprim
Reason 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 Terminated
Memantine Hydrochloride Extended-Release Capsules
Reason Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed Release Capsules USP
Reason Discoloration: product contains brown pellets
Class III · Low risk Terminated
R.E.C.K.
Reason Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class II · Moderate risk Terminated
Infuvite PEDiatric Pharmacy
Reason Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I · High risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter - found in reserve sample vials at the firm.
Class III · Low risk Terminated
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ
Reason Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk Terminated
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ
Reason Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk Terminated
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ
Reason Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason 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 Terminated
Ceftazidime for Injection USP and Dextrose for Injection USP
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Class I · High risk Terminated
KORE ORGANIC CBD Oil Watermelon 15mg*
Reason Chemical Contamination; product contains elevated levels of lead
Class II · Moderate risk Terminated
Nizatidine Oral Solution
Reason CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class II · Moderate risk Terminated
Cefixime for Oral Suspension USP
Reason Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Class II · Moderate risk Terminated
Acetaminophen and Codeine Phosphate 300/30 mg tablet
Reason cGMP Deviations
Class I · High risk Terminated
Finasteride Plus 1.25 mg Capsule
Reason Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
Class II · Moderate risk Terminated
Estradiol
Reason cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II · Moderate risk Terminated
Levothyroxin
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Betahistine 16 mg Capsule 180 capsules bottle
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Testosterone w/Cosmetic HRT Base 20 mg
Reason Lack of Processing Control