Home / Recalls / Par Pharmaceutical Inc. / D-1542-2020

D-1542-2020 Class II Terminated

Recalled by Par Pharmaceutical Inc. — Chestnut Ridge, NY

Recall Details

Product Type
Drugs
Report Date
September 2, 2020
Initiation Date
August 10, 2020
Termination Date
June 7, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,347 bottles

Product Description

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

Reason for Recall

Failed Impurity /Degradation Specifications

Distribution Pattern

Product was distributed to 9 major distributors throughout the United States.

Code Information

Lot # 32091002, exp. date May 2021

Other recalls by Par Pharmaceutical Inc.

  • D-1071-2020 Class II — Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharm (March 30, 2020)
  • D-1035-2020 Class III — PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Ph (March 4, 2020)
  • D-0843-2020 Class III — Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets p (February 10, 2020)
  • D-1293-2019 Class I — Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, (April 30, 2019)
  • D-1185-2018 Class III — Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-co (September 6, 2018)
  • D-0154-2017 Class II — Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx on (October 5, 2016)
  • D-0120-2017 Class III — Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg (September 27, 2016)
  • D-0119-2017 Class III — Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.0 (September 27, 2016)
  • D-0123-2017 Class III — Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, (September 27, 2016)
  • D-0122-2017 Class III — Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, (September 27, 2016)