FDAFDA · Food and drugs·Recall number D-1342-2014
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Published May 28, 2014 · Recall initiated: May 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROMETHAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- Nationwide
- Lot
- Lot #: MN9081, Expiry: 09/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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