West-ward Pharmaceutical Corp.

FDA Drug Class III Terminated

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 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 0

May 13, 2015 West-ward Pharmaceutical Corp. 14,649 Cartons units

FDA Drug Class II Terminated

VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceuti

October 2, 2014 West-ward Pharmaceutical Corp. 5,596 HDPE bottles units

FDA Drug Class II Terminated

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07

May 20, 2014 West-ward Pharmaceutical Corp. a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles units

FDA Drug Class II Terminated

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd

November 7, 2013 West-ward Pharmaceutical Corp. 20,534 bottles units

FDA Drug Class II Terminated

Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distr

September 23, 2013 West-ward Pharmaceutical Corp. 9813 vials units

FDA Drug Class II Terminated

Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distri

September 23, 2013 West-ward Pharmaceutical Corp. 9020 vials units

FDA Drug Class II Terminated

Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown,

July 30, 2013 West-ward Pharmaceutical Corp. 51,704 bottles units

FDA Drug Class II Terminated

Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J.,

July 30, 2013 West-ward Pharmaceutical Corp. 1000 count bottles/61,370 and 5000 count bottles/321 units

FDA Drug Class II Terminated

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown

June 4, 2013 West-ward Pharmaceutical Corp. 118 bottles units

FDA Drug Class II Terminated

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Ea

May 16, 2013 West-ward Pharmaceutical Corp. 14,503 bottles units

FDA Drug Class II Terminated

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724

May 16, 2013 West-ward Pharmaceutical Corp. 7,324 bottles units

FDA Drug Class III Terminated

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 --

May 13, 2013 West-ward Pharmaceutical Corp. Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials units

FDA Drug Class II Terminated

Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Phar

March 18, 2013 West-ward Pharmaceutical Corp. 1,258 bottles units

FDA Drug Class II Terminated

Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; ND

March 18, 2013 West-ward Pharmaceutical Corp. 3, 061 bottles units

FDA Drug Class II Terminated

Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01

February 6, 2013 West-ward Pharmaceutical Corp. 7,136 units units

FDA Drug Class II Terminated

Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets p

January 7, 2013 West-ward Pharmaceutical Corp. 6,511 bottles units

FDA Drug Class III Terminated

Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.

January 7, 2013 West-ward Pharmaceutical Corp. 1,185 Bottles units

FDA Drug Class II Terminated

Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharma

December 7, 2012 West-ward Pharmaceutical Corp. 43,075 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical C

December 7, 2012 West-ward Pharmaceutical Corp. 32,550 bottles units

FDA Drug Class II Terminated

Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceu

December 7, 2012 West-ward Pharmaceutical Corp. 8,585 bottles units

FDA Drug Class II Terminated

PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical

December 5, 2012 West-ward Pharmaceutical Corp. 128,319 bottles units

FDA Drug Class II Terminated

PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-

December 5, 2012 West-ward Pharmaceutical Corp. 60,289 bottles units

FDA Drug Class II Terminated

Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharm

December 4, 2012 West-ward Pharmaceutical Corp. 77531 bottles units

FDA Drug Class III Terminated

Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.

November 30, 2012 West-ward Pharmaceutical Corp. 1763 bottles units

FDA Drug Class II Terminated

VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pa

November 30, 2012 West-ward Pharmaceutical Corp. 18,825 bottles units

FDA Drug Class II Terminated

Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured b

November 30, 2012 West-ward Pharmaceutical Corp. 43,478 bottles units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Port

April 13, 2012 West-ward Pharmaceutical Corp. a) 74,960 vials; b) 911,070 vials units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portuga

April 13, 2012 West-ward Pharmaceutical Corp. a) 308,275 vials; b) 2,008,850 vials units