Par Pharmaceutical, Inc.
Par Pharmaceutical, Inc. appears in FDA public data with 17 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1542-2020, Class II) was initiated on August 10, 2020.
Summary
- Total Recalls
- 17 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1542-2020 | Class II | BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 | August 10, 2020 |
| D-1071-2020 | Class II | Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut | March 30, 2020 |
| D-1035-2020 | Class III | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnu | March 4, 2020 |
| D-0843-2020 | Class III | Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, | February 10, 2020 |
| D-1293-2019 | Class I | Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par | April 30, 2019 |
| D-1185-2018 | Class III | Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only | September 6, 2018 |
| D-0154-2017 | Class II | Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE E | October 5, 2016 |
| D-0122-2017 | Class III | Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and fer | September 27, 2016 |
| D-0121-2017 | Class III | Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous | September 27, 2016 |
| D-0119-2017 | Class III | Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count | September 27, 2016 |
| D-0123-2017 | Class III | Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and fe | September 27, 2016 |
| D-0120-2017 | Class III | Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a | September 27, 2016 |
| D-1038-2016 | Class III | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufact | May 28, 2016 |
| D-0234-2016 | Class III | Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01 | October 26, 2015 |
| D-0233-2016 | Class III | Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034 | October 26, 2015 |
| D-0393-2015 | Class II | Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, | February 12, 2015 |
| D-0332-2015 | Class II | HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmace | November 24, 2014 |