The Recall Desk
CriticalFDA (Drugs)·D-1328-2014·Announced 2014-05-28

Pfizer Recalls Effexor XR Capsules Due to Foreign Tablet Contamination

Pfizer is recalling specific lots of Effexor XR 150 mg capsules because a foreign Tikosyn capsule was found in a bottle.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Pfizer US Pharmaceutical Group is recalling 49,847 bottles of Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg. The affected products are packaged in 30-count and 90-count Unit of Use bottles and were distributed nationwide and in Puerto Rico. The recall involves Lot V130142 (Expiration 10/15) and Lot V130140 (Expiration 10/15).

The recall was initiated after a pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach-colored capsule printed with "TKN250." This foreign capsule was identified as a Tikosyn (dofetilide) capsule. The presence of a different medication in the packaging poses a risk of accidental ingestion of the wrong drug.

Consumers with these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
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 subs
Affected units
49,847

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Pfizer Us Pharmaceutical Group

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