Drug Enforcement D-017-2014

Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.

Status

Terminated

Classification

Class II

Report Date

December 4, 2013

Termination Date

August 4, 2014

Product Information

Product description
Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.
Product quantity
4,844 bottles
Reason for recall
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Apotex Inc.
Address
150 Signet Drive, N/A

Canada
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-017-2014
Event ID
66807
Recall initiation date
July 17, 2013
Center classification date
November 22, 2013
Code info
Lot # KF2199 Exp 07/15
More code info
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