Reported Aug 14, 2019 · Terminated
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC…
American Health Packaging
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: American Health Packaging · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only
- Manufactured byLupin Limited, Goa 403 722 INDIA For BluePoint Laboratories
- Lot codes and dates
Lot #: a) G702705 and b) G702706Exp. 3/31/2020
- Amount recalled
- 14,360 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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