Class II · Moderate risk
Venlafaxine Tablets
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Venlafaxine HCl Extended-Release Capsules
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Affected NDC
59762-0182-02
Compare with the code on your package — it is the most precise check available.
Drug: Venlafaxine Category: Mental Health Medication
- Recalling firm
- Greenstone Llc
- NDC code
- 59762-0182-2
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1361-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Venlafaxine recalls
See all
Class III · Low risk
Venlafaxine Extended-Release Tablets
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk
Venlafaxine Hydrochloride
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class II · Moderate risk
Venlafaxine Tablets
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Other recalls by Greenstone Llc
All 2014 recalls
Class II · Moderate risk
methylprednisolone tablets
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Class II · Moderate risk
sertraline HCl tablets
Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life
Class III · Low risk
Glipizide XL
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Class II · Moderate risk
Nifedipine
Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
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