Moderate riskFDA DrugClass II

Preferred Pharmaceuticals ondansetron ODT recalled for unsealed packs

Preferred Pharmaceuticals is recalling ondansetron ODT 4mg tablets because the blister pack containers are not fully sealed, which can cause tablets to fall out. The manufacturer Glenmark Pharmaceuticals notified Preferred Pharmaceuticals of the sealing defect. This affects specific lot numbers distributed nationwide.

From the FDA notice · Read the official notice ↗ · All Preferred Pharmaceuticals recalls

What to do

  1. Check if you have ondansetron ODT 4mg tablets from Preferred Pharmaceuticals with lot number J1325J, I1725P, or expiration date 4/30/2027
  2. Do not use tablets from an unsealed or damaged blister pack
  3. Dispose of affected tablets safely and contact your pharmacy or doctor for a replacement

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
575 1x10 Foil Blister Packs
Illnesses reported
None reported
Manufactured in
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Classification
Class II
Recall number
D-0239-2026

In the FDA's words

Description
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01 Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. Lot: J1325J, I1725P, EXP Date: 4/30/2027. Distribution: Natinowide in the USA Affected quantity: 575 1x10 Foil Blister Packs
Hazard
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

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