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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79142

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 13, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hetero Labs Limited Unit V

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

2 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 2

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60

D-0601-2018
Recall number
D-0601-2018
Initiated
February 13, 2018
Classification
Class II
Status
Terminated
Quantity
1764 60-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Code information

Lot #s VGC17040 & VGC17041, EXP 07/2019

Distribution pattern

NJ and then distributed Nationwide in the USA

drug · product 2 of 2

Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30

D-0602-2018
Recall number
D-0602-2018
Initiated
February 13, 2018
Classification
Class II
Status
Terminated
Quantity
48132 60-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Code information

Lot # VLC17027 Exp 07-2019

Distribution pattern

NJ and then distributed Nationwide in the USA