Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
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
Class II · Moderate risk
Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar
Lack of Processing Control
Class II · Moderate risk
Paregoric Alternate Elixir 300 mL bottle
Lack of Processing Control
Class II · Moderate risk
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar
Lack of Processing Control
Class II · Moderate risk
Bi-Est (8:2)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control