NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Ge...
FDA Drug Recall #D-1701-2012 — Class II — July 6, 2012
Recall Summary
| Recall Number | D-1701-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 6, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Glenmark Generics Inc., USA |
| Location | Mahwah, NJ |
| Product Type | Drugs |
| Quantity | unknown |
Product Description
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Reason for Recall
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
Other Recalls from Glenmark Generics Inc., USA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1229-2014 | Class II | Ranitidine Tablets USP, 150 mg, 500-count bottl... | Mar 18, 2014 |
| D-329-2013 | Class III | Glenmark Gabapentin Tablets, a) 600mg, 500- cou... | Apr 5, 2013 |
| D-330-2013 | Class III | Glenmark Pravastatin Sodium Tablets ,40 mg, 90-... | Apr 5, 2013 |
| D-331-2013 | Class III | Glenmark Topiramate Tablets, 200 mg, 60-count ... | Apr 5, 2013 |
| D-182-2013 | Class III | Montelukast Sodium Tablets, 10 mg (base), packa... | Feb 13, 2013 |
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.