Recall Enforment Report D-0215-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Seaway Pharma Inc., originally initiated on 12-28-2023 for the product Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4. The product was recalled due to cgmp deviations: firm reported possible microbial contamination in the purified water used in the manufacturing of the products. no contamination was found in the final products.. The product was distributed in Mi, Pa 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-0215-2024	12-28-2023	01-10-2024	Class II	4,176 bottles	Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.	Ongoing
D-0216-2024	12-28-2023	01-10-2024	Class II	7,992 bottles	Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.	Ongoing
D-0214-2024	12-28-2023	01-10-2024	Class II	7,992 bottles	Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.	Ongoing
D-0217-2024	12-28-2023	01-10-2024	Class II	8,160 bottles	Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
63868-605	Oxymetazoline Hydrochloride	Oxymetazoline Hydrochloride	Spray	Nasal	Chain Drug Marketing Association Inc.	Human Otc Drug
63868-607	Oxymetazoline Hydrochloride	Oxymetazoline Hydrochloride	Spray	Nasal	Chain Drug Marketing Association Inc.	Human Otc Drug
63868-608	Oxymetazoline Hydrochloride	Oxymetazoline Hydrochloride	Solution	Nasal	Chain Drug Marketing Association Inc	Human Otc Drug
63868-676	Oxymetazoline Hydrochloride	Oxymetazoline Hydrochloride	Spray	Nasal	Chain Drug Marketing Association Inc.	Human Otc Drug

Field Name	Field Value
Event ID	93708 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0215-2024 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	MI, PA 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	Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
Reason For Recall	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4,176 bottles 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	01-10-2024
Recall Initiation Date	12-28-2023 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	Letter 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	Seaway Pharma Inc.
Code Info	Lot # SD23033, Exp 04/30/2025 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.
Status	Ongoing

Field Name	Field Value
Event ID	93708 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0216-2024 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	MI, PA 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	Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
Reason For Recall	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	7,992 bottles 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	01-10-2024
Recall Initiation Date	12-28-2023 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	Letter 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	Seaway Pharma Inc.
Code Info	Lot # SE23034, Exp 05/31/2026 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	63868-605-01; 63868-676-01
Status	Ongoing

Field Name	Field Value
Event ID	93708 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0214-2024 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	MI, PA 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	Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
Reason For Recall	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	7,992 bottles 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	01-10-2024
Recall Initiation Date	12-28-2023 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	Letter 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	Seaway Pharma Inc.
Code Info	Lot # SD23032, Exp 04/30/2026 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	63868-607-01
Status	Ongoing

Field Name	Field Value
Event ID	93708 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0217-2024 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	MI, PA 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	Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
Reason For Recall	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	8,160 bottles 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	01-10-2024
Recall Initiation Date	12-28-2023 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	Letter 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	Seaway Pharma Inc.
Code Info	Lot # SE23035, Exp 05/31/2026 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	63868-608-01
Status	Ongoing