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- Recall Enforcement Event ID: 90270
Recall Enforment Report D-0978-2022
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Family Dollar Stores, Llc., originally initiated on 05-17-2022 for the product AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g) The product was recalled due to cgmp deviations: product stored outside of labeled temperature requirements.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0978-2022 | 05-17-2022 | 06-08-2022 | Class II | N/A | AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g) | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
| D-0977-2022 | 05-17-2022 | 06-08-2022 | Class II | N/A | AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
| D-0975-2022 | 05-17-2022 | 06-08-2022 | Class II | Unknown | Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL) | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
| D-0979-2022 | 05-17-2022 | 06-08-2022 | Class II | N/A | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6 | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
| D-0976-2022 | 05-17-2022 | 06-08-2022 | Class II | N/A | AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
| D-0981-2022 | 05-17-2022 | 06-08-2022 | Class II | Unknown | Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7 | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
| D-0980-2022 | 05-17-2022 | 06-08-2022 | Class II | N/A | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9 | cGMP deviations: product stored outside of labeled temperature requirements. | Ongoing |
Recall Enforcement Report D-0978-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0978-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g)
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2097153 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0977-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0977-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g)
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2024219 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0975-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0975-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL)
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Unknown Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2096628. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0979-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0979-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2007625 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0976-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0976-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2024222 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0981-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0981-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Unknown Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2005444 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0980-2022
- Event ID
- 90270 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0980-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9
- Reason For Recall
- cGMP deviations: product stored outside of labeled temperature requirements. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-08-2022
- Recall Initiation Date
- 05-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Family Dollar Stores, Llc.
- Code Info
- SKUs 2007626 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Ongoing
