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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89033

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

Open FDA event record

Event summary

Timeline bucket
November 17, 2021
Product types
Drug
Classifications
Class I
Statuses
Completed
Recalling firm wording
Sandoz 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

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

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64

D-0286-2022
Recall number
D-0286-2022
Initiated
November 17, 2021
Classification
Class I
Status
Completed
Recalling firm
Sandoz Inc
Quantity
45,036 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse; temperature excursion during shipping

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse; temperature excursion during shipping

Code information

Lot #SAB06761A, exp 04/2023

Distribution pattern

Nationwide in the US