FDAClass IIMay 26, 2021

Preferred Pharmaceuticals Inc recall: Nitrosamine Impurity

Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs…

Why was Preferred Pharmaceuticals Inc recalled?

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022

Product
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs…
Recalling firm
Preferred Pharmaceuticals, Inc.
Quantity
147 bottles (14,700 extended release tablets)
Distribution
Distributed to two physician consignees located in FL.
Recall date
May 26, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls