Recalls / Class II
Class IID-017-2014
Product
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.
- Brand name
- Acyclovir
- Generic name
- Acyclovir
- Active ingredient
- Acyclovir
- Route
- Oral
- NDCs
- 60505-5306, 60505-5307
- FDA application
- ANDA077309
- Affected lot / code info
- Lot # KF2199 Exp 07/15
Why it was recalled
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Recalling firm
- Firm
- Apotex Inc.
- Manufacturer
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, N/A N/A, Canada
Distribution
- Quantity
- 4,844 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-07-17
- FDA classified
- 2013-11-22
- Posted by FDA
- 2013-12-04
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-017-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.