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.
FDA Drug Recalls
832 recalls, newest first
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.
Class II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class I · High risk
Finasteride Plus 1.25 mg Capsule
Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
Class II · Moderate risk
Estradiol
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II · Moderate risk
Levothyroxin
Lack of Processing Control
Class II · Moderate risk
Betahistine 16 mg Capsule 180 capsules bottle
Lack of Processing Control
Class II · Moderate risk
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository
Lack of Processing Control
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
Class II · Moderate risk
Testosterone w/Cosmetic HRT Base 20 mg
Lack of Processing Control
Class II · Moderate risk
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar
Lack of Processing Control
Class II · Moderate risk
Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube
Lack of Processing Control