PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 6, 2017 Initiated: October 12, 2017 #D-0099-2018

Product Description

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)

Details

Units Affected
4050 bottles
Distribution
NJ
Location
Hyderabad, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Hetero Labs, Ltd. - Unit III. Units affected: 4050 bottles.
Why was this product recalled?
Presence of foreign substance (screw)
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2017. Severity: Moderate. Recall number: D-0099-2018.