Hetero Labs, Ltd. - Unit III recalls
FDA enforcement reports naming Hetero Labs, Ltd. - Unit III as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- Oct 3, 2018
- Oct 3, 2018Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Ph…Drug · Hetero Labs, Ltd. - Unit IIIPresence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.Class III
- Aug 8, 2018Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber…Drug · Hetero Labs, Ltd. - Unit IIIFailed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.Class II
- Feb 14, 2018Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber P…Drug · Hetero Labs, Ltd. - Unit IIICGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.Class II
- Jan 24, 2018Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber P…Drug · Hetero Labs, Ltd. - Unit IIIPresence of foreign substance: metallic razor blade was found in one bottle.Class III
- Dec 6, 2017Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx…Drug · Hetero Labs, Ltd. - Unit IIIPresence of foreign substance (screw)Class II