Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of U...

FDA Drug Recall #D-1328-2014 — Class I — March 6, 2014

Recall Summary

Recall Number D-1328-2014
Classification Class I — Serious risk
Date Initiated March 6, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pfizer Us Pharmaceutical Group
Location New York, NY
Product Type Drugs
Quantity 49,847 bottles

Product Description

Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.

Reason for Recall

Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.

Distribution Pattern

Nationwide and Puerto Rico

Lot / Code Information

Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15

Other Recalls from Pfizer Us Pharmaceutical Group

Recall # Classification Product Date
D-1409-2014 Class II Pristiq (desvenlafaxine) Extended-Release Table... Apr 16, 2014
D-1166-2014 Class III Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhyd... Feb 26, 2014
D-014-2014 Class II Aldactone (spironolactone) tablets, USP, 100 mg... Sep 4, 2013

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.