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.
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.
Lot numbers, UPCs & expiration codes
Lot # KF2199 Exp 07/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-017-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2013
- FDA report date
- Dec 4, 2013
- Quantity
- 4,844 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-017-2014, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 66807
- Address
- 150 Signet Drive
- Code information
- Lot # KF2199 Exp 07/15
- Report date
- Dec 4, 2013
- Product type
- Drugs
- Recall number
- D-017-2014
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 4,844 bottles
- Termination date
- Aug 4, 2014
- Reason for recall
- Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 17, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2013