D-017-2014 Class II Terminated
FDA drug recall D-017-2014 was initiated by Apotex Inc. on Jul 17, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 4,844 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 17, 2013
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,844 bottles
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.
Reason for recall
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot # KF2199 Exp 07/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-017-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026