Par Pharmaceutical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
17 (1 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1542-2020Class IIBusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01August 10, 2020
D-1071-2020Class IIGlycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut March 30, 2020
D-1035-2020Class IIIPrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical ChestnuMarch 4, 2020
D-0843-2020Class IIIFrovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, February 10, 2020
D-1293-2019Class IMycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par April 30, 2019
D-1185-2018Class IIIPramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx onlySeptember 6, 2018
D-0154-2017Class IITravoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EOctober 5, 2016
D-0120-2017Class IIIGildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (aSeptember 27, 2016
D-0119-2017Class IIIGildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 countSeptember 27, 2016
D-0123-2017Class IIIGildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and feSeptember 27, 2016
D-0122-2017Class IIIGildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferSeptember 27, 2016
D-0121-2017Class IIIGildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrousSeptember 27, 2016
D-1038-2016Class IIIPramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, ManufactMay 28, 2016
D-0233-2016Class IIIMeclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034October 26, 2015
D-0234-2016Class IIIMeclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01October 26, 2015
D-0393-2015Class IIMafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet,February 12, 2015
D-0332-2015Class IIHydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par PharmaceNovember 24, 2014