RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III ___________________________________
PRODUCT
ZANTAC 75 (Ranitidine) Tablets 75 mg, 1 Tablet (1 dose), Acid Reducer, Recall # D-216-2008 CODE Lot #A14991, Expiration Date: 12/2008 RECALLING FIRM/MANUFACTURER  Recalling Firm: Boehringer Ingelheim Roxane Inc., Columbus, OH, by letter on May 5, 2008.
Manufacturer: DSM Pharmaceuticals Inc., Greenville, SC. Firm initiated recall is ongoing. 
REASON
Exceeded Impurities Specification: (S-oxide) VOLUME OF PRODUCT IN COMMERCE 2,279,200 tablets DISTRIBUTION Nationwide

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PRODUCT
AMIODARONE HCl Injection, 150mg/3mL (50mg/mL), 10 Single Use Vials, FOR IV USE ONLY, MUST BE DILUTED, Rx ONLY, Recall # D-217-2008 CODE Lot #1156947, Expiration Date: 12/09 RECALLING FIRM/MANUFACTURER Ben Venue Laboratories Inc, Bedford, OH, by letter on April 21, 2008. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter; vials contained crystallized active ingredient.
VOLUME OF PRODUCT IN COMMERCE
15,327 packs - 10 vials per pack (153,270 vials) DISTRIBUTION Nationwide