Medications & Supplements/Prescription Drugs

West-Ward Pharmaceuticals Corp.: Dexamethasone Sodium Phosphate Injection Recalled for Impurity Specifications

Agency Publication Date: November 22, 2017

Summary

West-Ward Pharmaceuticals Corp. has voluntarily recalled 18,053 units of Dexamethasone Sodium Phosphate Injection, USP (4 mg/mL), in both 1 mL and 5 mL vials. This prescription corticosteroid is being recalled because testing identified high levels of an impurity or degradation product known as Dexamethasone adduct, which exceeded the approved safety specifications. The affected medication was distributed nationwide in the United States and Puerto Rico in shelf packs containing 25 vials each.

Risk

The presence of impurities or degradation products above specified limits can potentially alter the safety or effectiveness of the medication. While the risk is categorized as low, using a drug that does not meet quality standards may not provide the intended therapeutic benefit or could cause unexpected side effects.

What You Should Do

Check your medication vials and outer shelf packs for the following NDC numbers: NDC 0641-6145-01 or NDC 0641-6145-25 (1 mL vials) and NDC 0641-6146-01 or NDC 0641-6146-25 (5 mL vials).
If you have the 1 mL vials, verify if the lot numbers match 106390, 106393, or 106395 with an expiration date of 10/18.
If you have the 5 mL vials, verify if the lot number matches 106352 with an expiration date of 10/18.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess these affected lots.
Return any unused product to the pharmacy or place of purchase for a refund and contact West-Ward Pharmaceuticals Corp. at their Eatontown, New Jersey location for further instructions.
For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials

Model:

NDC 0641-6145-01

NDC 0641-6145-25

Lot Numbers:

106390 (Exp 10/18)

106393 (Exp 10/18)

106395 (Exp 10/18)

Date Ranges: 10/18

Product: Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials

Model:

NDC 0641-6146-01

NDC 0641-6146-25

Lot Numbers:

106352 (Exp 10/18)

Date Ranges: 10/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78415

Status: Resolved

Manufacturer: West-Ward Pharmaceuticals Corp.

Manufactured In: United States

Units Affected: 2 products (16,157 shelf packs; 1,896 shelf packs)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication vials and outer shelf packs for the following NDC numbers: NDC 0641-6145-01 or NDC 0641-6145-25 (1 mL vials) and NDC 0641-6146-01 or NDC 0641-6146-25 (5 mL vials).

If you have the 1 mL vials, verify if the lot numbers match 106390, 106393, or 106395 with an expiration date of 10/18.

If you have the 5 mL vials, verify if the lot number matches 106352 with an expiration date of 10/18.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess these affected lots.

Return any unused product to the pharmacy or place of purchase for a refund and contact West-Ward Pharmaceuticals Corp. at their Eatontown, New Jersey location for further instructions.

For additional questions regarding this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials

Model:

NDC 0641-6145-01

NDC 0641-6145-25

Lot Numbers:

106390 (Exp 10/18)

106393 (Exp 10/18)

106395 (Exp 10/18)

Date Ranges: 10/18

Product: Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials

Model:

NDC 0641-6146-01

NDC 0641-6146-25

Lot Numbers:

106352 (Exp 10/18)

Date Ranges: 10/18