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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77323

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

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Event summary

Timeline bucket
May 16, 2017
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Lupin Limited (Unit 1)

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

Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202

D-1093-2017
Recall number
D-1093-2017
Initiated
May 16, 2017
Classification
Class I
Status
Terminated
Recalling firm
Lupin Limited (Unit 1)
Quantity
24,652 tablets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

Code information

Batch Number L600518; Exp. 05/18

Distribution pattern

Nationwide

Field note

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