West-Ward Pharmaceutical recalls
FDA enforcement reports naming West-Ward Pharmaceutical as the recalling firm.
- Recall reports
- 28
- Class I (serious)
- 0
- Most recent report
- Oct 12, 2016
- Oct 12, 2016PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, DistrDrug · West-Ward PharmaceuticalFailed Tablet/Capsule Specifications: Discovery of an underweight tablet.Class II
- Jun 24, 2015Fentanyl Citrate InjDrug · West-Ward Pharmaceutical Corp.Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).Class III
- Apr 1, 2015Fentanyl Citrate InjDrug · West-Ward Pharmaceutical CorporationFailed Impurities/Degradation Specifications; 12 month stability testing.Class III
- Nov 5, 2014VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle…Drug · West-Ward Pharmaceutical Corp.Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.Class II
- Jul 9, 2014Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottlesDrug · West-Ward Pharmaceutical Corp.Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.Class II
- Dec 25, 2013Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tabletsDrug · West-Ward Pharmaceutical Corp.Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testingClass II
- Aug 21, 2013Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000…Drug · West-Ward Pharmaceutical Corp.Presence of Foreign Substance: black specks comprised of degraded organic material found on tabletsClass II
- Aug 14, 2013Lisinopril Tablets, USP, 2Drug · West-Ward Pharmaceutical Corp.Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.Class II
- Aug 14, 2013VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx On…Drug · West-Ward Pharmaceutical Corp.Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.Class II
- Jul 31, 2013West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 01…Drug · West-Ward Pharmaceutical Corp.Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.Class II
- West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 01…
- Nicardipine Hydrochloride Injection 25 mg/10 mL (2
- Donnatal Extentabs, 0
- Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd
- Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-war…
- Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufacture…
- VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets
- Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100…
- Belladonna Alkaloids (hyoscyamine sulfate, USP 0
- Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: We…
- PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1…
- Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 014…
- PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1…
- Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count table…
- Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC…
- Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-12…
- Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single…
- Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single D…
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