Dexamethasone Sodium Phosphate Injection
FDA Recall NDC 0641-0367
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dexamethasone Sodium Phosphate (NDC 0641-0367). A significant event, classified as Class III, was initiated on Nov 06, 2017 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound)."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2017 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Nov 06, 2017
Nov 29, 2017
16,157 shelf packs
Recall Profile & Regulatory Data
Event ID
78415
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Apr 01, 2020
Product Description
Dexamethasone 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.
Batch or Lot Expiration Information
Lot# : 106390, 106393, 106395, Exp 10/18
Affected Packages Involved in this Recall
0641-0367-21Product
0641-0367-25Product
0641-6145-01Product
0641-6145-25Product
0641-6146-01Product
0641-6146-10Product
0641-6146-25Product
November 2017 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Nov 06, 2017
Nov 29, 2017
1,896 shelf packs
Recall Profile & Regulatory Data
Event ID
78415
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Apr 01, 2020
Product Description
Dexamethasone 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.
Batch or Lot Expiration Information
Lot# : 106352, Exp 10/18
Affected Packages Involved in this Recall
0641-0367-21Product
0641-0367-25Product
0641-6145-01Product
0641-6145-25Product
0641-6146-01Product
0641-6146-10Product
0641-6146-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
