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Hetero Labs, Ltd. - Unit III Recalls
5 recalls on record · December 6, 2017 to October 3, 2018 · Drugs
Recalls by year
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 3, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, N
Hazard: 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.
August 8, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscatawa
Hazard: Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
February 14, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,
Hazard: CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
January 24, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,
Hazard: Presence of foreign substance: metallic razor blade was found in one bottle.
December 6, 2017DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber P
Hazard: Presence of foreign substance (screw)