Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals Internation...
FDA Drug Recall #D-0019-2015 — Class III — May 21, 2014
Recall Summary
| Recall Number | D-0019-2015 |
| Classification | Class III — Low risk |
| Date Initiated | May 21, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Valeant Pharmaceuticals North America LLC |
| Location | Bridgewater, NJ |
| Product Type | Drugs |
| Quantity | 205,853 bottles |
Product Description
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
Reason for Recall
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Distribution Pattern
Nationwide
Lot / Code Information
VASOTEC 2.5MG TAB 30CT 12K015P exp. 9/30/2014 VASOTEC 2.5MG TAB 30CT 13G048P exp. 07/31/2015 VASOTEC 2.5MG TAB 30CT 14A065P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 13G020P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 12K020P exp. 9/30/2014 VASOTEC 2.5MG TAB 90CT 13B016P exp. 9/30/2014 VASOTEC 5MG TAB 30CT 13B022P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13B023P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13C015P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 13E002P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 14A002P exp. 11/30/2015 VASOTEC 5MG TAB 30CT 13L066P exp. 11/30/2015 VASOTEC 5MG TAB 90CT 13B018P exp. 2/28/2015 VASOTEC 5MG TAB 90CT 13G015P exp. 06/30/2015 VASOTEC 10MG TAB 90CT 12M017P exp. 11/30/2014 VASOTEC 10MG TAB 1000CT 12L105P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 12M016P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 13G013P exp. 06/30/2015 VASOTEC 10MG TAB 30CT 13J081P exp. 9/30/2015 VASOTEC 10MG TAB 90CT 12M025P exp. 11/30/2014 VASOTEC 10MG TAB 90CT 13J082P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J085P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J094P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13J098P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13G011P exp. 06/30/2015 VASOTEC 10MG TAB 1000CT 13J097P exp. 09/30/2015 VASOTEC 20MG TAB 30CT 12J017P exp. 5/31/2014 VASOTEC 20MG TAB 30CT 13C016P exp. 2/28/2015 VASOTEC 20MG TAB 30CT 13E003P exp. 02/28/2015 VASOTEC 20MG TAB 30CT 13L068P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J086P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J087P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 12M029P exp. 11/30/2014 VASOTEC 20MG TAB 90CT 12M030P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 12J023P exp. 5/31/2014 VASOTEC 20MG TAB 1000CT 12L108P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 13C088P exp. 02/28/2015 VASOTEC 20MG TAB 1000CT 13J099P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M054P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M055P exp. 12/31/2015 VASOTEC 20MG TAB 1000CT 14B054P exp. 12/31/2015
Other Recalls from Valeant Pharmaceuticals North America...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0487-2019 | Class III | Cardizem CD (diltiazem HCl) capsules, 120 mg, p... | Jan 30, 2019 |
| D-0490-2019 | Class III | Cardizem CD (diltiazem HCl) capsules, 300 mg, p... | Jan 30, 2019 |
| D-0488-2019 | Class III | Cardizem CD (diltiazem HCl) capsules, 180 mg, p... | Jan 30, 2019 |
| D-0491-2019 | Class III | Diltiazem HCl CD capsules, 360 mg, 90-count bot... | Jan 30, 2019 |
| D-0489-2019 | Class III | Cardizem CD (diltiazem HCl) capsules, 240 mg, p... | Jan 30, 2019 |
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.