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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79420

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

Open FDA event record

Event summary

Timeline bucket
March 07, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Pharmaceutical Ingredients LLC

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

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

Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

D-0591-2018
Recall number
D-0591-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Quantity
21 g

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Stability Data Does Not Support Expiry

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Code information

Lot 012517-1R

Distribution pattern

Nationwide in the USA.

drug · product 2 of 2

Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients

D-0592-2018
Recall number
D-0592-2018
Initiated
March 07, 2018
Classification
Class II
Status
Terminated
Quantity
1460 GM

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Stability Data Does Not Support Expiry

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Code information

Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;

Distribution pattern

Nationwide in the USA.