Reported May 28, 2014 · Terminated
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd.,…
Zydus Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only
- Manufactured byCadila Healthcared Ltd., India
- Distributed byZydus Pharmaceuticals USA Inc., Pennington, NJ 08534
- NDC68382-041-01
- Lot codes and dates
- Lot #: MN9081
- Expiry09/2015
- Amount recalled
- 10,200 bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
This product could cause temporary or reversible health problems — stop using it.
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