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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69928

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 04, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Micro Labs Usa, Inc S

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

3 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 3

Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540

D-0407-2015
Recall number
D-0407-2015
Initiated
December 04, 2014
Classification
Class III
Status
Terminated
Recalling firm
Micro Labs Usa, Inc S
Quantity
240 (1000-count bottle), 26,904 (90-count bottle)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Code information

Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.

Distribution pattern

Nationwide.

drug · product 2 of 3

Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.

D-0408-2015
Recall number
D-0408-2015
Initiated
December 04, 2014
Classification
Class III
Status
Terminated
Recalling firm
Micro Labs Usa, Inc S
Quantity
13488 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Code information

Lot #: STDG010, Exp 3/2015

Distribution pattern

Nationwide.

drug · product 3 of 3

Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.

D-0409-2015
Recall number
D-0409-2015
Initiated
December 04, 2014
Classification
Class III
Status
Terminated
Recalling firm
Micro Labs Usa, Inc S
Quantity
13464 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Code information

Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015

Distribution pattern

Nationwide.