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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61664

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

Open FDA event record

Event summary

Timeline bucket
April 02, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals USA, Inc.

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

Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78

D-1396-2012
Recall number
D-1396-2012
Initiated
April 02, 2012
Classification
Class II
Status
Terminated
Quantity
4188 cartons (5 X 5 blisterpacks)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.

Code information

Lot # 34000741A; Expiration date: 7/2013

Distribution pattern

Nationwide