Recalls / Class II
Class IID-0332-2015
Product
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
- Affected lot / code info
- Lot 26708501, Exp. 01/17
Why it was recalled
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Recalling firm
- Firm
- Par Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 RAM Ridge Rd, N/A, Spring Valley, New York 10977-6714
Distribution
- Quantity
- 38,788 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-11-24
- FDA classified
- 2015-01-06
- Posted by FDA
- 2015-01-14
- Terminated
- 2017-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0332-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.