Recalls / Class II
Class IID-1342-2014
Product
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
- Brand name
- Promethazine Hydrochloride
- Generic name
- Promethazine Hydrochloride
- Active ingredient
- Promethazine Hydrochloride
- Route
- Oral
- NDCs
- 68382-040, 68382-041, 68382-042
- FDA application
- ANDA040596
- Affected lot / code info
- Lot #: MN9081, Expiry: 09/2015
Why it was recalled
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 10,200 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-08
- FDA classified
- 2014-05-21
- Posted by FDA
- 2014-05-28
- Terminated
- 2016-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1342-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.