Drug Enforcement D-687-2013

Crystallization; crystallized nimodipine

Status

Terminated

Classification

Class II

Report Date

July 17, 2013

Termination Date

August 25, 2014

Product Information

Product description
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Product quantity
46387 Cartons
Reason for recall
Crystallization; crystallized nimodipine
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Sun Pharmaceutical Industries Inc.
Address
270 Prospect Plains Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-687-2013
Event ID
65501
Recall initiation date
May 21, 2013
Center classification date
July 8, 2013
Code info
Lot #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.
More code info
—