Exact FDA event identifier

Event 83792

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

Event summary

Timeline bucket: September 12, 2019
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Shire Human Genetic Therapies, 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

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

4 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 4

Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02

D-0035-2020

Recall number: D-0035-2020
Initiated: September 12, 2019
Classification: Class I
Status: Terminated
Recalling firm: Shire Human Genetic Therapies, Inc.
Quantity: 1,556

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Code information

08569357, exp 4/30/2020; 07983652, 08544833, exp 6/30/2021

Distribution pattern

Product was distributed throughout the United States.

drug · product 2 of 4

Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02

D-0036-2020

Recall number: D-0036-2020
Initiated: September 12, 2019
Classification: Class I
Status: Terminated
Recalling firm: Shire Human Genetic Therapies, Inc.
Quantity: 13,897

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Code information

06628461, exp 8/31/2020 06661658, 07110136, 7164106, 07761970 exp 10/31/2020 07630717, 08689119, exp 12/31/2020 07769458, exp 4/30/2021 07983643, 08003758, exp 6/30/2021 08214790, exp 8/31/2020 NY17002DA, NY17002DB, exp 6/30/2020

Distribution pattern

Product was distributed throughout the United States.

drug · product 3 of 4

Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02

D-0037-2020

Recall number: D-0037-2020
Initiated: September 12, 2019
Classification: Class I
Status: Terminated
Recalling firm: Shire Human Genetic Therapies, Inc.
Quantity: 15,075

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Code information

06628462, exp 5/31/2020 06651000, exp 9/30/2020 06661659, exp 6/30/2020 07110125, 07301073, exp 10/31/2020 07200435, 7/31/2020 07482211, exp 12/31/2020 07630714, exp 3/31/2021 NX170002DA, exp 12/31/2019 NX17004DA, exp 3/31/2020 NX17007DA, NX17007DB, NX17008DA exp 4/30/2020 NX17010DA, NX17012DA, exp 6/30/2020

Distribution pattern

Product was distributed throughout the United States.

drug · product 4 of 4

Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02

D-0038-2020

Recall number: D-0038-2020
Initiated: September 12, 2019
Classification: Class I
Status: Terminated
Recalling firm: Shire Human Genetic Therapies, Inc.
Quantity: 8,003

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Code information

06828752, exp 12/31/2019 07110118, exp 4/30/2021 07164107, exp 12/31/2019 07200436, 07301074, exp 4/30/2021 07482212, 07630715, exp 6/30/2021 07769460, exp 4/30/2021

Distribution pattern

Product was distributed throughout the United States.