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ANI Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0543-2026Class IIEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANIMay 12, 2026
D-0564-2022Class IIAlprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bFebruary 15, 2022
D-0566-2022Class IIAlprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count boFebruary 15, 2022
D-0567-2022Class IIAlprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count boFebruary 15, 2022
D-0568-2022Class IIPyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab LaboratoriesFebruary 15, 2022
D-0565-2022Class IIAlprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count boFebruary 15, 2022
D-0048-2021Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheOctober 9, 2020
D-0045-2021Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheOctober 9, 2020
D-0043-2021Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheOctober 9, 2020
D-0044-2021Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheOctober 9, 2020
D-0047-2021Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheOctober 9, 2020
D-0046-2021Class IIIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and AmpheOctober 9, 2020