Class II · Moderate risk
oxyTOCIN 30 Units/500 mL
Subpotent drug - Product did not contain drug.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Lisinopril Tablets
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class II · Moderate risk
Doxycycline Hyclate Tablets
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
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk
EcoLips Sport Lip Balm
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Class II · Moderate risk
Estriol USP Micronized 5 G
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk
Doxycycline Hyclate tablets USP
Failed dissolution specifications
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 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 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 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.