Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC...
FDA Drug Recall #D-1284-2014 — Class II — March 20, 2014
Recall Summary
| Recall Number | D-1284-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 20, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Caraco Pharmaceutical Laboratories, Ltd. |
| Location | Detroit, MI |
| Product Type | Drugs |
| Quantity | 91,777 bottles |
Product Description
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Reason for Recall
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Distribution Pattern
Nationwide and Puerto Rico
Lot / Code Information
Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.
Other Recalls from Caraco Pharmaceutical Laboratories, Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1510-2014 | Class II | Cephalexin Capsules, USP, 250 mg, packaged in a... | Jun 26, 2014 |
| D-1511-2014 | Class II | Cephalexin Capsules, USP, 500 mg, packaged in a... | Jun 26, 2014 |
| D-1415-2014 | Class II | Venlafaxine Hydrochloride Extended-Release Tabl... | Jun 12, 2014 |
| D-1296-2014 | Class III | Cetirizine Hydrochloride Chewable Tablets, 5 mg... | Apr 9, 2014 |
| D-1297-2014 | Class III | Children's Cetirizine Hydrochloride Chewable Ta... | Apr 9, 2014 |
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.