Exact FDA event identifier

Event 80699

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

Event summary

Timeline bucket: August 02, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Pharmcore 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

9 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 9

Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1147-2018

Recall number: D-1147-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 5718 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.

Code information

Lots: HCG50319 Exp. 4/30/2019; HCG50316 Exp. 3/31/2019; HCG50317 Exp. 4/30/2019; HCG50315 Exp. 3/31/2019; HCG50318 Exp. 4/30/2019; HCG50320 Exp. 4/30/2019; HCG50321 Exp. 4/30/2019; HCG50311 Exp. 3/31/2019; HCG50310 Exp. 3/31/2019; HCG50309 Exp. 3/31/2019; HCG50313 Exp. 3/31/2019; HCG50314 Exp. 3/31/2019;

Distribution pattern

Nationwide

drug · product 2 of 9

Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1148-2018

Recall number: D-1148-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 864 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.

Code information

Lots: HCG1116 Exp. 3/31/2019; HCG1117 Exp. 4/30/2019

Distribution pattern

Nationwide

drug · product 3 of 9

Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1149-2018

Recall number: D-1149-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 355 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.

Code information

Lots: HCG22038 Exp. 3/31/2019; HCG22039 Exp. 4/30/2019

Distribution pattern

Nationwide

drug · product 4 of 9

Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1150-2018

Recall number: D-1150-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 3070 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.

Code information

Lots: HCG25112 Exp. 2/28/2019; HCG25110 Exp. 1/31/2019; HCG25115 Exp. 4/30/2019; HCG25114 Exp. 4/30/2019; HCG25111 Exp. 2/28/2019

Distribution pattern

Nationwide

drug · product 5 of 9

Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1151-2018

Recall number: D-1151-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 2085 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.

Code information

Lots: HCG40160 Exp. 2/28/2019; HCG40161 Exp. 4/30/2019; HCG40159 Exp. 2/28/2019; HCG40162 Exp. 4/30/2019; HCG50308 Exp. 2/28/2019

Distribution pattern

Nationwide

drug · product 6 of 9

Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1152-2018

Recall number: D-1152-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 3351 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.

Code information

Lots: HCG60122 Exp. 4/30/2019; HCG60124 Exp. 6/30/2019; HCG60121 Exp. 4/30/2019; HCG60123 Exp. 5/31/2019; HCG60120 Exp. 4/30/2019; HCG60118 Exp. 2/28/2019; HCG1115 Exp. 1/31/2019

Distribution pattern

Nationwide

drug · product 7 of 9

Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1153-2018

Recall number: D-1153-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 6 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.

Code information

Lot: IPA3-17 Exp. 07/2018

Distribution pattern

Nationwide

drug · product 8 of 9

Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1154-2018

Recall number: D-1154-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 1115 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.

Code information

Lots: MTLY-19 Exp. 10/31/2018; MTLY-18 Exp. 8/31/2018

Distribution pattern

Nationwide

drug · product 9 of 9

Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

D-1155-2018

Recall number: D-1155-2018
Initiated: August 02, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pharmcore Inc.
Quantity: 599 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.

Code information

Lots: IPA9-15 Exp. 3/31/2019; IPA9-14 Exp. 1/31/2019

Distribution pattern

Nationwide