Recall events
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Event 75300
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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
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
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
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8921]
FDA event record
· Exact recall-number query on openFDA
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
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
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8701]
FDA event record
· Exact recall-number query on openFDA
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
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
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7154]
FDA event record
· Exact recall-number query on openFDA
