FDA Recall D-1328-2014
Pfizer Us Pharmaceutical Group · New York, NY
Class I — life-threatening Terminated 1161 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 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.
Recall record
- Recall number
D-1328-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2014-03-06
- Classified by FDA Center
- 2014-05-20
- FDA published
- 2014-05-28
- Terminated
- 2017-05-10
- Recalling firm
- Pfizer Us Pharmaceutical Group
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- EFFEXOR
- Generic name(s)
- VENLAFAXINE HYDROCHLORIDE
- Manufacturer(s)
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- NDC(s)
0008-0836, 0008-0837, 0008-0833- Route(s)
- ORAL