FDA recall D-0913-2023

Product

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

Reason for recall

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Distribution

Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-07-05

Report date

2023-07-19

Termination date

2024-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0913-2023