Exact FDA event identifier

Event 76756

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

Event summary

Timeline bucket: March 22, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Novartis Pharmaceuticals Corp.

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

2 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 2

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15

D-0678-2017

Recall number: D-0678-2017
Initiated: March 22, 2017
Classification: Class III
Status: Terminated
Recalling firm: Novartis Pharmaceuticals Corp.
Quantity: N/A

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.

Code information

Lot #: 244661F, Exp. Feb 2018

Distribution pattern

nationwide

drug · product 2 of 2

Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

D-0679-2017

Recall number: D-0679-2017
Initiated: March 22, 2017
Classification: Class III
Status: Terminated
Recalling firm: Novartis Pharmaceuticals Corp.
Quantity: N/A

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.

Code information

Lot #: 244660F, Exp. FEB 2018

Distribution pattern

nationwide