Recall: D-1211-2018

Class III - Minor Violations

Class IIIClassification

2018-09-12Initiated

TerminatedStatus

Hetero Labs, Ltd. - Unit IIIFirm

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.

Distribution

Indiana and Louisiana

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.