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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63031

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 21, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Caraco Pharmaceutical Laboratories Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-003-2013
Recall number
D-003-2013
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Quantity
a) 2424 Cartons b) 2675 Cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: Presence of crystals of Nimodipine within the capsule solution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Presence of crystals of Nimodipine within the capsule solution.

Code information

Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13

Distribution pattern

One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts