FDA-Drug2017-12-06Class II

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

Hetero Labs, Ltd. - Unit III
Hazard

Presence of foreign substance (screw)

Sold states
NJ
Affected count
4050 bottles
Manufactured in
Plot 22-110, Part Ii, Ida, Rangareddy, Jeedimetla, Hyderabad, N/A, India
Products
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

Official notice

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

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