West-ward Pharmaceutical Corp.

FDA Regulatory Profile

Summary

Total Recalls
29
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0008-2017Class IIPredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp.October 3, 2016
D-1139-2015Class IIIFentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use PrMay 13, 2015
D-0172-2015Class IIVERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, MaOctober 2, 2014
D-1414-2014Class IIIsoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000May 20, 2014
D-367-2014Class IICarisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. EaNovember 7, 2013
D-66447-001Class IIIrinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx September 23, 2013
D-66447-002Class IIIrinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, RxSeptember 23, 2013
D-853-2013Class IILisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b)July 30, 2013
D-883-2013Class IIBelladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0July 30, 2013
D-839-2013Class IIVersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for June 4, 2013
D-825-2013Class IIWest-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),RMay 16, 2013
D-824-2013Class IIWest-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), May 16, 2013
D-691-2013Class IIINicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. bMay 13, 2013
D-306-2013Class IIDonnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured ByMarch 18, 2013
D-242-2013Class IIEthambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: VersMarch 18, 2013
D-220-2013Class IICiprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward PharmaceutiFebruary 6, 2013
D-170-2013Class IIBelladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamiJanuary 7, 2013
D-164-2013Class IIIGlycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward PharmJanuary 7, 2013
D-150-2013Class IICarisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) anDecember 7, 2012
D-130-2013Class IILisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 10December 7, 2012