The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0601-2018·Announced 2018-03-21

Valganciclovir Tablets Recalled Due to Temperature Exposure During Shipping

Hetero Labs Limited is recalling Valganciclovir Tablets 450 mg because they were exposed to high temperatures during shipping. The recall covers 1,764 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is temperature abuse, which is a quality control issue rather than a direct toxicological hazard, and no illnesses or injuries are reported in the source text.

Plain-English summary

Hetero Labs Limited Unit V is recalling 1,764 bottles of Valganciclovir Tablets USP 450 mg. The recall was initiated because the medication was exposed to higher temperatures at an airport or in cargo. This exposure occurred in the same consignment as a complaint batch of Famciclovir.

The affected product is Valganciclovir Tablets USP 450 mg, 60-count bottles, manufactured for Camber Pharmaceuticals, Inc. The specific lots involved are VGC17040 and VGC17041, with an expiration date of 07/2019. The product was distributed in New Jersey and then nationwide in the USA.

Consumers should check their medication for the lot numbers VGC17040 or VGC17041 and an expiration date of 07/2019. If the product matches these details, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
VALGANCICLOVIR (VALGANCICLOVIR)
Brand
VALGANCICLOVIR
Manufacturer
Hetero Labs Limited Unit V
Category
Drug — Antiviral
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #s VGC17040 & VGC17041
  • EXP 07/2019

UPCs (1)

  • 0331722832601

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hetero Labs Limited Unit V under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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