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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79114

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

Open FDA event record

Event summary

Timeline bucket
February 07, 2018
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Pfizer 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

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01

D-0596-2018
Recall number
D-0596-2018
Initiated
February 07, 2018
Classification
Class I
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
53600 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Code information

Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

D-0597-2018
Recall number
D-0597-2018
Initiated
February 07, 2018
Classification
Class I
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
29, 680 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Code information

Lot 71330DD EXP. 11/1/2018.

Distribution pattern

Nationwide in the USA