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Hetero Labs, Ltd. - Unit III

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Hetero Labs, Ltd. - Unit III are currently shown as ongoing. The 5 records below are historical recall records.

Public Health Trace has 5 recalls naming Hetero Labs, Ltd. - Unit III as the recalling firm, republished from official FDA and USDA sources.

Recall history - 5 terminated records

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20171
20184
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FDA Recall TerminatedTerminated: November 29, 2018Historical recordClass III

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

by Hetero Labs, Ltd. - Unit III

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.
Published
October 3, 2018
Distribution
Indiana and Louisiana

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FDA Recall TerminatedTerminated: July 15, 2021Historical recordClass II

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

by Hetero Labs, Ltd. - Unit III

Reason
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Published
August 8, 2018
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 21, 2020Historical recordClass II

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30

by Hetero Labs, Ltd. - Unit III

Reason
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Published
February 14, 2018
Distribution
NJ Only

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FDA Recall TerminatedTerminated: March 23, 2018Historical recordClass III

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10

by Hetero Labs, Ltd. - Unit III

Reason
Presence of foreign substance: metallic razor blade was found in one bottle.
Published
January 24, 2018
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 3, 2020Historical recordClass II

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

by Hetero Labs, Ltd. - Unit III

Reason
Presence of foreign substance (screw)
Published
December 6, 2017
Distribution
NJ

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Showing 1–5 of 5 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Hetero Labs, Ltd. - Unit III as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.