FDA recall D-0099-2018

Hetero Labs, Ltd. - Unit III · Class II · drug

Product

Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47

Reason for recall

Presence of foreign substance (screw)

Distribution

NJ

Key facts

Status
Terminated
Initiation date
2017-10-12
Report date
2017-12-06
Termination date
2020-09-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hyderabad, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2018