Food, drugs, devices › West-ward Pharmaceutical Corp.

Drug recall: Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Scien

FDA enforcement event 65287 · Class III · initiated 13 May 2013 · status Terminated · terminated 17 Mar 2015

DrugVoluntary: Firm initiated1 product recordEatontown, NJ

FDA enforcement event 65287 is a drug recall by West-ward Pharmaceutical Corp. of Eatontown, NJ, initiated 13 May 2013 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. 26% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 17 Mar 2015. Initiation: voluntary: firm initiated. West-ward Pharmaceutical Corp. has 24 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

West-ward Pharmaceutical Corp., Eatontown, NJ.

Reason for recall

"Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-691-2013	Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10	Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials	Class III	Terminated	17 Jul 2013

Context

26%of 2013 drug events are Class III370 events that year

1product record in this eventfirm median: 1

24events on this register for the firm

Other enforcement events for West-ward Pharmaceutical Corp.

Initiated	Product (first record)	Type	Class	Records
13 May 2015	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25	Drug	Class III	1
2 Oct 2014	VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for Versa	Drug	Class II	1
20 May 2014	Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC	Drug	Class II	1
7 Nov 2013	Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mf	Drug	Class II	1
23 Sep 2013	Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured b	Drug	Class II	2
30 Jul 2013	Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles	Drug	Class II	1
30 Jul 2013	Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bot	Drug	Class II	1
4 Jun 2013	VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorpora	Drug	Class II	1
16 May 2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle	Drug	Class II	2
18 Mar 2013	Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated,	Drug	Class II	1

All 24 events for West-ward Pharmaceutical Corp.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)"

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: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Mar 2015. "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.