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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68841

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2014
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
Unique Pharmaceutical, Ltd

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

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

D-0011-2015
Recall number
D-0011-2015
Initiated
July 18, 2014
Classification
Class I
Status
Terminated
Quantity
3,529 Vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

Code information

Lot #: 86513, Exp 07/23/2014

Distribution pattern

Nationwide

drug · product 2 of 2

All sterile products within expiry

D-0012-2015
Recall number
D-0012-2015
Initiated
July 18, 2014
Classification
Class II
Status
Terminated
Quantity
325,225 units (syringes, vials, bags)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Code information

All Lots

Distribution pattern

Nationwide

Field note

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