Glipizide XL extended-release tablets 5 mg 500-tablet bottle recalled over manufacturing violations

Recall date

September 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapa…

Recall number

D-0010-2019

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations; rejected product was used to manufacture final bulk lot

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2