Multi-event August 2018 FDA Recall Drug by Pharmcore Inc.

This Multi-event Class II drug recall was voluntarily initiated by Pharmcore Inc. on August 2, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1155-2018 TERMINATED D-1152-2018 TERMINATED D-1148-2018 TERMINATED D-1149-2018 TERMINATED D-1150-2018 TERMINATED D-1154-2018 TERMINATED D-1153-2018 TERMINATED D-1147-2018 TERMINATED D-1151-2018 TERMINATED

Recall Number: D-1155-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
599 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

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

Recall Number: D-1152-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
3351 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1148-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
864 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

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

Recall Number: D-1149-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
355 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

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

Recall Number: D-1150-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
3070 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1154-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
1115 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

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

Recall Number: D-1153-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

Lot# Lot: IPA3-17 Exp. 07/2018

Recall Number: D-1147-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
5718 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-1151-2018

Reason for Recall
Lack of assurance of sterility.
Initiated
08-02-2018
Reported
09-05-2018
Quantity
2085 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmcore Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2022
Product Description About Product Description
Full technical description of the product.
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Batch or Lot Expiration Information

Lot# 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