Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranb...

FDA Drug Recall #D-1086-2014 — Class II — January 16, 2014

Recall Summary

Recall Number D-1086-2014
Classification Class II — Moderate risk
Date Initiated January 16, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ranbaxy Inc.
Location Princeton, NJ
Product Type Drugs
Quantity 64,626 bottles

Product Description

Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90

Reason for Recall

Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Distribution Pattern

Nationwide

Lot / Code Information

2407255, 2407256 Exp. 05/14

Other Recalls from Ranbaxy Inc.

Recall # Classification Product Date
D-1288-2015 Class II Absorica (isotretinoin) Capsules, 25 mg, Packag... Jun 26, 2015
D-162-2013 Class III Lac-Hydrin (ammonium lactate) Lotion, 12%, pack... Dec 27, 2012
D-163-2013 Class III Lac-Hydrin (ammonium lactate) Cream, 12%, packa... Dec 27, 2012
D-070-2013 Class II Atorvastatin Calcium Tablets, 10 mg, 90 tablets... Nov 9, 2012
D-071-2013 Class II Atorvastatin Calcium Tablets, 20 mg, 90 tablets... Nov 9, 2012

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.