Par Pharmaceutical recalls
FDA enforcement reports naming Par Pharmaceutical as the recalling firm.
- Recall reports
- 17
- Class I (serious)
- 1
- Most recent report
- Sep 2, 2020
- Sep 2, 2020BusPIRone Hydrochloride Tablets, USP 7Drug · Par Pharmaceutical Inc.Failed Impurity /Degradation SpecificationsClass II
- Apr 8, 2020Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, DistDrug · Par Pharmaceutical Inc.Failed Impurities/Degradation Specification: Presence of unknown impurity observed.Class II
- Mar 25, 2020PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceu…Drug · Par Pharmaceutical Inc.Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mgClass III
- Feb 19, 2020Frovatriptan Succinate Tablets, 2Drug · Par Pharmaceutical Inc.Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.Class III
- May 15, 2019Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distrib…Drug · Par Pharmaceutical, Inc.Presence of Particulate Matter; glass fragment observed in one vial of reconstituted productClass I
- Sep 19, 2018Pramipexole dihydrochloride extended release tablets, 0Drug · Par Pharmaceutical, Inc.Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.Class III
- Dec 7, 2016Travoprost Ophthalmic Solution USP, 0Drug · Par Pharmaceutical, Inc.Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the containerClass II
- Nov 9, 2016Gildess 24 FE 1Drug · Par Pharmaceutical, Inc.Subpotent Drug; Ethinyl EstradiolClass III
- Nov 9, 2016Gildess 1Drug · Par Pharmaceutical, Inc.Subpotent Drug; Ethinyl EstradiolClass III
- Nov 9, 2016Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP),…Drug · Par Pharmaceutical, Inc.Subpotent Drug; Ethinyl EstradiolClass III
- Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0
- Gildess FE 1
- Pramipexole Dihydrochloride Extended Release Tablets, 0
- Meclizine Hydrochloride Tablets, USP, 12
- Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC:…
- Mafenide Acetate, USP, For 5% Topical Solution, STERILE
- HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by:…
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