Multi-event August 2014 FDA Recall Drug by New Gpc Inc.

This Multi-event Class II drug recall was voluntarily initiated by New Gpc Inc. on August 7, 2014 for the product Drug. The FDA reported the reason for recall as does not meet monograph. The product was distributed in New York and the recall is currently terminated.

Reported Recall Events

D0031-2015 TERMINATED D0029-2015 TERMINATED D0032-2015 TERMINATED D0033-2015 TERMINATED D0030-2015 TERMINATED D0034-2015 TERMINATED D0035-2015 TERMINATED

Recall Number: D0031-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Initiated
08-07-2014
Reported
10-29-2014
Quantity
1320 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 305150, 312236, 311231

Recall Number: D0029-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Initiated
08-07-2014
Reported
10-29-2014
Quantity
690 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 201158, 307056, 311457

Recall Number: D0032-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Initiated
08-07-2014
Reported
10-29-2014
Quantity
36 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 305206

Recall Number: D0033-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Initiated
08-07-2014
Reported
10-29-2014
Quantity
360 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 308289

Recall Number: D0030-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Initiated
08-07-2014
Reported
10-29-2014
Quantity
900 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 304159, 211463, 308345

Recall Number: D0034-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.
Initiated
08-07-2014
Reported
10-29-2014
Quantity
4320 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 202504, 310455

Recall Number: D0035-2015

Reason for Recall
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.
Initiated
08-07-2014
Reported
10-29-2014
Quantity
2,304 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69206
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.
New Gpc 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.

Batch or Lot Expiration Information

Batch# Batch Numbers: 311478, 305207