Multi-event August 2022 FDA Recall Drug by Family Dollar Stores, Llc.

This Multi-event Class II drug recall was voluntarily initiated by Family Dollar Stores, Llc. on August 10, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-1467-2022 ONGOING D-1466-2022 ONGOING D-1465-2022 ONGOING D-1470-2022 ONGOING D-1468-2022 ONGOING D-1469-2022 ONGOING

Recall Number: D-1467-2022

Reason for Recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Initiated
08-10-2022
Reported
09-07-2022
Quantity
1680 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90774
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Family Dollar Stores, Llc.
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Product Description About Product Description
Full technical description of the product.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Batch or Lot Expiration Information

Lot# SKUs 999749 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Recall Number: D-1466-2022

Reason for Recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Initiated
08-10-2022
Reported
09-07-2022
Quantity
840 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90774
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Family Dollar Stores, Llc.
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Product Description About Product Description
Full technical description of the product.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Batch or Lot Expiration Information

Lot# SKUs 999088 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Recall Number: D-1465-2022

Reason for Recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Initiated
08-10-2022
Reported
09-07-2022
Quantity
1120 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90774
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Family Dollar Stores, Llc.
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Product Description About Product Description
Full technical description of the product.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Batch or Lot Expiration Information

Lot# SKUs 998277 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Recall Number: D-1470-2022

Reason for Recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Initiated
08-10-2022
Reported
09-07-2022
Quantity
840 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90774
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Family Dollar Stores, Llc.
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Product Description About Product Description
Full technical description of the product.
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.

Batch or Lot Expiration Information

Lot# SKUs 999043 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Recall Number: D-1468-2022

Reason for Recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Initiated
08-10-2022
Reported
09-07-2022
Quantity
840 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90774
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Family Dollar Stores, Llc.
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Product Description About Product Description
Full technical description of the product.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Batch or Lot Expiration Information

Lot# SKUs 998909 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

Recall Number: D-1469-2022

Reason for Recall
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Initiated
08-10-2022
Reported
09-07-2022
Quantity
1400 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90774
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Family Dollar Stores, Llc.
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.
Other
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
Product Description About Product Description
Full technical description of the product.
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

Batch or Lot Expiration Information

Lot# SKUs 999750 distributed to Family Dollar retail stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT