Class II · Moderate risk Ongoing
acyclovir sodium
Reason Lack of Assurance of Sterility
Acyclovir Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
What was recalled
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
- Recalling firm
- Apace KY LLC
- NDC code
- 50268-061-11
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0544-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Acyclovir recalls
See all
Class III · Low risk Completed
Valacyclovir Tablets USP
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class II · Moderate risk Ongoing
Acyclovir Oral Suspension
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Acyclovir Sodium Injection 1
Reason Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk Completed
Acyclovir Sodium Injection
Reason Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
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