Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per car...
FDA Drug Recall #D-0544-2018 — Class II — February 9, 2018
Recall Summary
| Recall Number | D-0544-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 9, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Apace KY LLC |
| Location | Fountain Run, KY |
| Product Type | Drugs |
| Quantity | 630 cartons |
Product Description
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
Reason for Recall
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Distribution Pattern
Nationwide
Lot / Code Information
Lot: 19900, exp 05/2019
Other Recalls from Apace KY LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1035-2017 | Class II | Amantadine HCl Capsules, USP, 100 mg, Rx Only, ... | Jun 19, 2017 |
| D-1036-2017 | Class II | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tabl... | Jun 19, 2017 |
| D-0811-2016 | Class III | Minocycline Hydrochloride Capsules USP, 100 mg*... | Feb 12, 2016 |
| D-1683-2012 | Class III | Enalapril Maleate Tablet, USP 5mg 30 Tablet bot... | Sep 4, 2012 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.