Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
Acyclovir Tablets USP 800 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
60505-5307-01
Compare with the code on your package — it is the most precise check available.
Drug: Acyclovir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| acyclovir NDC 60505-5307 |
800 mg/1 | Tablet Oral |
Apotex Corp. | Rx |
- Recalling firm
- Apotex Inc.
- NDC code
- 60505-5307-1
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-017-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Acyclovir recalls
See all
Class II · Moderate risk
Acyclovir Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acyclovir Sodium Injection 1
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Other recalls by Apotex Inc.
All 2013 recalls
Class II · Moderate risk
Paxil CR
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Class II · Moderate risk
Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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