FDA Recall D-0385-2021

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Class II Ongoing 1842 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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 Inc.; Farmingdale NY, NDC #: 68788-6932-1

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

Quantity: 147 bottles (14,700 extended release tablets)

Reason for recall

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

Recall record

Recall number: D-0385-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Distributed to two physician consignees located in FL.
Recall initiated: 2021-04-28
Classified by FDA Center: 2021-05-16
FDA published: 2021-05-26
Recalling firm: Preferred Pharmaceuticals, Inc.
Firm location: Anaheim, CA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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