Reported Jul 9, 2014 · Terminated
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC…
West-Ward Pharmaceutical Corp.
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: West-Ward Pharmaceutical Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209
Is this the product you have?
Isoniazid TabletsUSP300 mgRx onlypackaged in a) 100-count bottlesNDC 0143-1261-01b) 1000-count bottlesNDC 0143-1261-10
- Manufactured by
West-ward Pharmaceutical CorpEatontownNJ 07724c) 30-count bottlesNDC 61748-013-30d) 100-count bottlesNDC 61748-013-01e) 1000-count bottlesNDC 61748-013-10Mfd
- forVersaPharm Incorporated, Marietta, GA 30062; Mfd
- byWest-ward Pharmaceutical Corp., Eatontown, NJ 07724
- Lot codes and dates
Lot #: a) 67839A67839DExp 05/1467936AExp 02/15b) 67839B67840CExp 05/1467936BExp 02/15c) 67840AExp 05/14d) 67840BExp 05/14e) 67839CExp 05/14
- Amount recalled
- a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
This product could cause temporary or reversible health problems — stop using it.
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