RecallRadar

FDA Drug recall D-0099-2018

Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc…

On 2017-12-06 the FDA classified a Class II recall of Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc… by Hetero Labs Unit Iii, citing presence of foreign substance (screw).

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0099-2018
ClassificationClass II
Statusterminated
Initiated2017-10-12
Published2017-12-06
Last updated2026-09-13 11:51 UTC
CompanyHetero Labs Unit Iii
DistributionNJ

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

Presence of foreign substance (screw)

Identifiers

ndc31722-574-47
code_infoLot # E170346, Exp 02/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0099-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.