Class II · Moderate risk
Naproxen Oral Suspension
Chemical contamination; presence of lead and lithium above specification
Naproxen Tablets USP (Naproxen Sodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
68462-0190-01
Compare with the code on your package — it is the most precise check available.
Drug: Naproxen Category: Pain Relief & OTC Medication
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 |
|---|---|---|---|---|
| Naproxen NDC 68462-0190 |
500 mg/1 | Tablet Oral |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Generics Inc., USA
- NDC code
- 68462-190-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1701-2012 · 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 Naproxen recalls
See all
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Tablets
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Other recalls by Glenmark Generics Inc., USA
All 2012 recalls
Class II · Moderate risk
Ranitidine Tablets USP
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Class III · Low risk
Glenmark Topiramate Tablets
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Class III · Low risk
Glenmark Pravastatin Sodium Tablets
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Class III · Low risk
Glenmark Gabapentin Tablets
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
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