FDA recall D-0594-2018

Product

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30

Reason for recall

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Distribution

NJ Only

Key facts

Status

Terminated

Initiation date

2018-01-10

Report date

2018-02-14

Termination date

2020-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hyderabad, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2018