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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75032

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

Open FDA event record

Event summary

Timeline bucket
August 24, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
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

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

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

D-1513-2016
Recall number
D-1513-2016
Initiated
August 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Sandoz Inc
Quantity
32,099 cartons

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Code information

Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

D-1514-2016
Recall number
D-1514-2016
Initiated
August 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Sandoz Inc
Quantity
a) 1,584 cartons; b) 62,170 vials

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Code information

Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16

Distribution pattern

Nationwide and Puerto Rico