FDA recall D-1019-2018

Product

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

Reason for recall

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-07-18

Report date

2018-08-08

Termination date

2021-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hyderabad, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1019-2018