FDA recall D-0094-2018

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-11-06

Report date

2017-11-29

Termination date

2020-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2018