Par Pharmaceutical recalls
Par Pharmaceutical appears in 17 official U.S. recall notices indexed by RecallRadar, most recently on 2020-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 17 |
|---|---|
| Published | 2015-01-14 to 2020-09-02 |
| By agency | FDA Drug (17) |
| By classification | Class III (11), Class II (5), Class I (1) |
| By status | terminated (12), completed (5) |
| Distribution named in notices | US |
Recalls
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
FDA Drug · Class II · 2020-09-02 · Par Pharmaceutical
Reason: Failed Impurity /Degradation Specifications - Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par F…
FDA Drug · Class II · 2020-04-08 · Par Pharmaceutical
Reason: Failed Impurities/Degradation Specification: Presence of unknown impurity observed. - PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
FDA Drug · Class III · 2020-03-25 · Par Pharmaceutical
Reason: Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg - Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services…
FDA Drug · Class III · 2020-02-19 · Par Pharmaceutical
Reason: 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. - Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977…
FDA Drug · Class I · 2019-05-15 · Par Pharmaceutical
Reason: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product - Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical,…
FDA Drug · Class III · 2018-09-19 · Par Pharmaceutical
Reason: Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels. - Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by…
FDA Drug · Class II · 2016-12-07 · Par Pharmaceutical
Reason: Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container - Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b)…
FDA Drug · Class III · 2016-11-09 · Par Pharmaceutical
Reason: Subpotent Drug; Ethinyl Estradiol - Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 bl…
FDA Drug · Class III · 2016-11-09 · Par Pharmaceutical
Reason: Subpotent Drug; Ethinyl Estradiol - Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28…
FDA Drug · Class III · 2016-11-09 · Par Pharmaceutical
Reason: Subpotent Drug; Ethinyl Estradiol - Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count…
FDA Drug · Class III · 2016-11-09 · Par Pharmaceutical
Reason: Subpotent Drug; Ethinyl Estradiol - Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and…
FDA Drug · Class III · 2016-11-09 · Par Pharmaceutical
Reason: Subpotent Drug; Ethinyl Estradiol - Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, I…
FDA Drug · Class III · 2016-06-22 · Par Pharmaceutical
Reason: Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification leve… - Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-03…
FDA Drug · Class III · 2015-11-25 · Par Pharmaceutical
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities. - Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884…
FDA Drug · Class III · 2015-11-25 · Par Pharmaceutical
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities. - Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label ---…
FDA Drug · Class II · 2015-03-04 · Par Pharmaceutical
Reason: Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene - HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc
FDA Drug · Class II · 2015-01-14 · Par Pharmaceutical
Reason: Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.