Food, drugs, devices › Par Pharmaceutical, Inc.

Drug recall: Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: P

FDA enforcement event 80969 · Class III · initiated 6 Sep 2018 · status Terminated · terminated 6 Dec 2019

DrugVoluntary: Firm initiated1 product recordChestnut Ridge, NY

FDA enforcement event 80969 is a drug recall by Par Pharmaceutical, Inc. of Chestnut Ridge, NY, initiated 6 Sep 2018 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 6 Dec 2019. Initiation: voluntary: firm initiated. Par Pharmaceutical, Inc. has 11 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Par Pharmaceutical, Inc., Chestnut Ridge, NY.

Reason for recall

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

Distribution

"United States nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
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	16,207 (bottles of 30 tablets)	Class III	Terminated	19 Sep 2018

Context

29%of 2018 drug events are Class III367 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for Par Pharmaceutical, Inc.

Initiated	Product (first record)	Type	Class	Records
10 Aug 2020	BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01	Drug	Class II	1
30 Mar 2020	Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.	Drug	Class II	1
4 Mar 2020	PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, ND	Drug	Class III	1
10 Feb 2020	Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Alm	Drug	Class III	1
30 Apr 2019	Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestn	Drug	Class I	1
5 Oct 2016	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 In	Drug	Class II	1
27 Sep 2016	Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (ND	Drug	Class III	5
26 Oct 2015	Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct	Drug	Class III	2
12 Feb 2015	Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharma	Drug	Class II	1
24 Nov 2014	HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, In	Drug	Class II	1

All 11 events for Par Pharmaceutical, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "United States nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 6 Dec 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.