Recalls / Class II
Class IID-1352-2015
Product
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
- Brand name
- Hydrochlorothiazide
- Generic name
- Hydrochlorothiazide
- Active ingredient
- Hydrochlorothiazide
- Route
- Oral
- NDCs
- 29300-128, 29300-129, 29300-485
- FDA application
- ANDA040907
- Affected lot / code info
- Lot #: GHYL15028, Exp April 2018
Why it was recalled
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Recalling firm
- Firm
- Unichem Pharmaceuticals Usa Inc
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 201 W Passaic St Ste 403, N/A, Rochelle Park, New Jersey 07662-3128
Distribution
- Quantity
- 4776 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-30
- FDA classified
- 2015-08-25
- Posted by FDA
- 2015-09-02
- Terminated
- 2018-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1352-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.