Doxazosin 2 mg tablets recalled for manufacturing practice deviations
RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with cGMP deviations affecting a prescription medication and no reported illnesses or injuries. This qualifies as a risk-of-harm product per the rubric's Score 3 criterion.
Plain-English summary
RemedyRepack Inc. is recalling Doxazosin 2 mg tablets due to current Good Manufacturing Practice (cGMP) deviations. The affected products are packaged in 30-count (NDC 70518-1560-00) and 90-count (NDC 70518-1560-01) bottles and were distributed nationwide to consignees within the United States.
The affected lot numbers include J0665197-120522 (expiration 12/31/2023), J0642497-082722 (expiration 09/30/2023), J0638552-080922 (expiration 08/31/2023), and B1808799-081622 (expiration 05/31/2024). In total, 58 bottles of the 30-count packaging and 6 bottles of the 90-count packaging were included in this recall.
This is a voluntary recall initiated by the firm.
The recalled product
- Product
- Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: a) J0665197-120522
- Exp. Date 12/31/2023
- J0642497-082722
- Exp. Date 09/30/2023 J0638552-080922
- Exp. Date 08/31/2023. Lot #: b) B1808799-081622
- Exp. Date 05/31/2024
Distribution
Distributed nationwide across the United States.
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