FDA recall D-0917-2023

Product

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.

Reason for recall

Presence of Particulate Matter: Particulate matter identified as fiber.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-07-03

Report date

2023-07-19

Termination date

2024-10-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0917-2023