Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76120

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 29, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Hetero Drugs Ltd. - Unit 1

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90

D-0453-2017
Recall number
D-0453-2017
Initiated
December 29, 2016
Classification
Class III
Status
Terminated
Quantity
20,412 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Code information

Lot #: FIN16002, Exp. 03/2018

Distribution pattern

NJ only.