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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75300

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

Open FDA event record

Event summary

Timeline bucket
September 22, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals USA

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

3 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 3

PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.

D-0109-2017
Recall number
D-0109-2017
Initiated
September 22, 2016
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
32,015 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Code information

Lot #: 13013.013A, Exp 04/17

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 3

PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.

D-0110-2017
Recall number
D-0110-2017
Initiated
September 22, 2016
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
5,556 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Code information

Lot #: 13016.011A, Exp 03/17

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 3

PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.

D-0111-2017
Recall number
D-0111-2017
Initiated
September 22, 2016
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
5,398 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Code information

Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17

Distribution pattern

Nationwide and Puerto Rico