FDA recall D-0223-2018

Product

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10

Reason for recall

Presence of foreign substance: metallic razor blade was found in one bottle.

Distribution

U.S.A. nationwide

Key facts

Status

Terminated

Initiation date

2017-12-22

Report date

2018-01-24

Termination date

2018-03-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hyderabad, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2018