The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-017-2014·Announced 2013-12-04

Apotex Recalls Acyclovir Tablets Due to Embedded Nitrile Rubber Glove Fragments

Apotex Inc. is recalling 4,844 bottles of Acyclovir 800 mg tablets (Lot KF2199) because some tablets may contain embedded pieces of nitrile rubber glove.

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, and the hazard involves foreign material (nitrile rubber) in tablets without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Apotex Inc. is recalling 4,844 bottles of Acyclovir Tablets USP 800 mg (NDC 60505-5307-1) under FDA recall number D-017-2014. The affected product is identified by Lot # KF2199 and an expiration date of 07/15. The recall was initiated because tablets from this lot may contain pieces of nitrile rubber glove embedded within them.

The recalled product was distributed nationwide and in Puerto Rico. It is a prescription-only medication manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, Florida.

Consumers and healthcare providers should check their inventory for Acyclovir 800 mg tablets with Lot # KF2199 and stop using them if found. Patients should contact their healthcare provider for guidance on alternative treatment options.

The recalled product

Product
ACYCLOVIR (ACYCLOVIR)
Brand
ACYCLOVIR
Manufacturer
Apotex Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
4,844

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 (1)

  • Lot # KF2199 Exp 07/15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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