Exact FDA event identifier

Event 74319

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

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Event summary

Timeline bucket: June 07, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Lyne Laboratories, 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

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

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

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48

D-1062-2016

Recall number: D-1062-2016
Initiated: June 07, 2016
Classification: Class III
Status: Terminated
Recalling firm: Lyne Laboratories, Inc.
Quantity: 12,215 Bottles shipped to Rising Pharmaceuticals

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotency: product assayed and found OOS for cyproheptadine

Code information

Lot #: CR1603, Exp 12/17

Distribution pattern

NJ