Par Pharmaceutical Inc. Recalls

All product recalls associated with Par Pharmaceutical Inc..

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Recall Summary

Total Recalls

16

Past Year

0

Class I (Serious)

1

Most Recent

Aug 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–16 of 16 recalls

BusPIRone Tablets (Par Pharmaceutical) - Impurity Specs (2020)

Failed Impurity /Degradation Specifications

Class IIModerate

FDAAug 10, 2020Nationwide• Par Pharmaceutical Inc.

Glycopyrrolate Tablets (Par) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Class IIModerate

FDAMar 30, 2020Nationwide• Par Pharmaceutical Inc.

Prednisone Tablets (Par) – Incorrect Expiration Date (2020)

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

Class III

Low

FDAMar 4, 2020Nationwide• Par Pharmaceutical Inc.

Frovatriptan Tablets (Par) – Incorrect Expiration Date (2020)

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 IIILow

FDAFeb 10, 2020Nationwide• Par Pharmaceutical Inc.

Mycophenolate Mofetil Injection (Par) – Glass Fragment (2019)

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

Class IHigh

FDAApr 30, 2019Nationwide• Par Pharmaceutical, Inc.

Pramipexole ER Tablets (Par) – impurity concern (2018)

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

Class IIILow

FDASep 6, 2018Nationwide• Par Pharmaceutical, Inc.

Travoprost Solution (Par) – Sterility Risk (2016)

Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container

Class IIModerate

FDAOct 5, 2016Nationwide• Par Pharmaceutical, Inc.