Multi-event May 2023 FDA Recall Drug by Remedyrepack Inc.

This Multi-event Class II drug recall was voluntarily initiated by Remedyrepack Inc. on May 1, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distrituded to three direct account in PA. and the recall is currently ongoing.

Reported Recall Events

D-0578-2023 ONGOING D-0577-2023 ONGOING D-0576-2023 TERMINATED

Recall Number: D-0578-2023

Reason for Recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Initiated
05-01-2023
Reported
05-24-2023
Quantity
29 x 30-count card, 1 x 100 UD box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92239
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.
RemedyRepack 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.
Product was distrituded to three direct account in PA.
Product Description About Product Description
Full technical description of the product.
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01

Batch or Lot Expiration Information

Lot# Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024

Recall Number: D-0577-2023

Reason for Recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Initiated
05-01-2023
Reported
05-24-2023
Quantity
12 5mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92239
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.
RemedyRepack 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.
Product was distrituded to three direct account in PA.
Product Description About Product Description
Full technical description of the product.
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;

Batch or Lot Expiration Information

Lot# B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024

Recall Number: D-0576-2023

Reason for Recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Initiated
05-01-2023
Reported
05-24-2023
Quantity
9,038 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92239
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.
RemedyRepack 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.
Product was distrituded to three direct account in PA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00

Batch or Lot Expiration Information

Lot# B2169656-032223, B2169663-032223, B2169680-032223, B2169713-032223, B2109085-021423, B2109094-021423, B2049229-010623, B2049235-010623, Exp. Date 04/30/2025; B2049224-010623, B2027905-122222, B2027920-122222, B2027941-122222, B2027968-122222, B2027979-122222, B2027989-122222, B2005343-120922, B2005333-120922, Exp. Date 03/31/2025; B1970782-112122, Exp. Date 01/31/2025; B1878510-092922, Exp. Date 11/30/2024; B1904609-101322, B1866210-092222, Exp. Date 12/31/2024; B1711316-060222, B1711328-060222, Exp. Date 09/30/2024; B1660244-042522, Exp. Date 07/31/2024; B1660288-042522, B1617673-032422, Exp. Date 06/30/2024; B1617737-032422, B1617744-032422, B1563407-021422, B1563498-021422, Exp. Date 05/31/2024; B1539158-012822, B1518050-011222, B1498175-122921, Exp. Date 04/30/2024; B1498194-122921, B1455889-112621, B1455918-112621, Exp. Date 03/31/2024; B1455901-112621, B1396346-101421, B1383216-100721, Exp. Date 01/31/2024; B1383214-100721, B1353451-091721, B1353463-091721, B1353480-091721, B1274069-071521, B1274079-071521, B1274052-071521, B1234313-061721, B1234339-061721, B1203592-052721, B1203608-052721, B1163740-042921, Exp. Date 09/30/2023; B1163745-042921, B1163747-042921, B1140139-040821, Exp. Date 05/31/2023.