RecallRadar

FDA Drug recall D-1211-2018

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc

On 2018-10-03 the FDA classified a Class III recall of Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc by Hetero Labs Unit Iii, citing presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1211-2018
ClassificationClass III
Statusterminated
Initiated2018-09-12
Published2018-10-03
Last updated2026-09-13 11:52 UTC
CompanyHetero Labs Unit Iii
DistributionIN, LA

Product

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Reason

Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

Identifiers

ndc31722-595-30
ndc31722-595-90
ndc31722-595-31
ndc31722-595-32
ndc31722-596-30
ndc31722-596-90
ndc31722-596-31
ndc31722-596-32
code_infoLot #: E181370, Exp. 5/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1211-2018%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.