Chestnut Ridge, NY, United States
Par Pharmaceutical Inc. recalls
6 recalls recorded since 2018, most recently on 10 August 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)1
Terminated Class II Drugs
- Recall started
- 10 August 2020
- Terminated
- 7 June 2021
- Reason
- Failed Impurity /Degradation Specifications
- Distribution
- Product was distributed to 9 major distributors throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1542-2020
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Terminated Class II Drugs
- Recall started
- 30 March 2020
- Terminated
- 2 November 2021
- Reason
- Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
- Distribution
- Product was distributed within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1071-2020
- Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in In
Terminated Class III Drugs
- Recall started
- 4 March 2020
- Terminated
- 9 April 2021
- Reason
- Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1035-2020
- PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Terminated Class III Drugs
- Recall started
- 10 February 2020
- Terminated
- 17 November 2020
- 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.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0843-2020
- Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut
Terminated Class I Drugs
- Recall started
- 30 April 2019
- Terminated
- 20 June 2023
- Reason
- Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1293-2019
- Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
Terminated Class III Drugs
- Recall started
- 6 September 2018
- Terminated
- 6 December 2019
- Reason
- Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
- Distribution
- United States nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1185-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.