FDA recall record

Legacy Pharmaceutical Packaging Metformin Hydrochloride Tablets USP, 1000 mg, 60-count recall — FDA D-1626-2020

Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.

Class IIIclassification
D-1626-2020official record ID
Oct 7, 2020report date

Recall record at a glance

Official recordD-1626-2020
CategoryDrug Recalls
ClassificationClass III
FDA record statusTerminated
Recalling firmLegacy Pharmaceutical Packaging LLC
Report dateOct 7, 2020
Recall initiation dateSep 24, 2020
Quantity111,948 bottles
LocationEarth City, MO, United States

Official product description

Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59

Why the product was recalled

Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.

Distribution information

Walmart distribution centers in GA and AR

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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