Class II · Moderate risk
Infuvite PEDiatric Pharmacy
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
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 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 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
Class II · Moderate risk
Bi-Est
Lack of Processing Control
Class II · Moderate risk
Bi-Est (8:2)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (50/50)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (50/50)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control
Class II · Moderate risk
Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube
Lack of Processing Control