Home / Recalls / Par Pharmaceutical, Inc. / D-1185-2018

D-1185-2018 Class III Terminated

Recalled by Par Pharmaceutical, Inc. — Chestnut Ridge, NY

Recall Details

Product Type
Drugs
Report Date
September 19, 2018
Initiation Date
September 6, 2018
Termination Date
December 6, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,207 (bottles of 30 tablets)

Product Description

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Reason for Recall

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

Distribution Pattern

United States nationwide

Code Information

Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.

Other recalls by Par Pharmaceutical, Inc.

  • 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 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-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)