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Drug recall · FDA · Published November 6, 2017

West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

🇺🇸 FDA recall #D-0093-2018DrugWest-Ward Pharmaceuticals Corp. ›
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Recalling firmWest-Ward Pharmaceuticals Corp.401 Industrial Way West, N/A · Eatontown, NJ 07724-2209
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/41105-west-ward-pharmaceuticals-corp-recalls-dexamethasone-sodium-phosphate-injection-usp · Recall date November 6, 2017 · FDA enforcement record: FDA #D-0093-2018

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“West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per.” GovInfoNow, recall dated November 6, 2017. https://govinfonow.com/recall/41105-west-ward-pharmaceuticals-corp-recalls-dexamethasone-sodium-phosphate-injection-usp. Based on FDA recall #D-0093-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0093-2018%22&limit=1).

How to tell if you have this one

  • Brand
    West-Ward Pharmaceuticals Corp.
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    Nationwide in the USA and Puerto Rico
  • NDC
    0641-0367-21, 0641-0367-25, 0641-6145-01, 0641-6145-25, 0641-6146-01, 0641-6146-10, 0641-6146-25
Recall numberProduct, codes & lotsQuantity
D-0093-2018Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.; Lot #: 106390, 106393, 106395, Exp 10/1816,157 shelf packs
D-0094-2018Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.; Lot #: 106352, Exp 10/181,896 shelf packs
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Contact West-Ward Pharmaceuticals Corp.

We’ve drafted a message you can send West-Ward Pharmaceuticals Corp. to request your refund or repair — edit it as you like.

Subject: Recall D-0093-2018 — West-Ward Pharmaceuticals Corp. West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosph

Hello,

I own a West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per that is covered by recall D-0093-2018 from West-Ward Pharmaceuticals Corp..

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0093-2018 (November 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0093-2018 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA