Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Some bottles may contain mixed strengths of the product.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class II · Moderate risk Terminated
EcoLips Sport Lip Balm
Reason 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 Terminated
Estriol USP Micronized 5 G
Reason Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk Terminated
Doxycycline Hyclate tablets USP
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets USP
Reason 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 Terminated
Sterile Curcumin 50mg/mL
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Curcumin
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Sterile Cannabidiol
Reason Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk Terminated
Carbamazepine Tablets
Reason Failed Dissolution Specifications
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 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 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 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 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