Drug product
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
D-0332-2015
Product summary
- Event
- Event 69999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38,788 bottles
- Official record key
drug-enforcement:D-0332-2015
Official wording
Reason: Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Code information: Lot 26708501, Exp. 01/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance