Reported Apr 5, 2023 · Terminated
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b)…
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
- Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only
- Packaged as
a) 30-count bottleNDC 61919-0009-30b) 90-count bottleNDC 61919-0009-90
- Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534
- Lot codes and dates
- a) [30 count bottles] Lot
- expiry
20JU2211exp 5/31/2024b) [90 count bottles] Lot
- expiry
25JU2128exp 12/31/202313SE2132exp 12/31/202325JU2133exp 12/31/202316JU2127exp 12/31/202318MY2126exp 12/31/202310JU2111exp 12/31/202314SE2111exp 1/31/202414JY2115exp 1/31/202425OC2113exp 2/29/202421SE2227exp 2/29/202410DE2123exp 3/31/202422NO2115exp 3/31/202421JA2202exp 4/30/202429DE2110exp 4/30/202428FE2227exp 4/30/202406JU2208exp 5/31/202430MA2229exp 5/31/202430AU2216exp 6/30/202423NO2203exp 6/30/202414DE2216exp 7/31/202512JA2305exp 7/31/2025
- Amount recalled
- 90 count: 495 bottles; 30 count: 13 bottles
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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