FDAFDA · Food and drugs·Recall number D-0385-2021
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
Published May 26, 2021 · Recall initiated: April 28, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Distributor
- Distributed to two physician consignees located in FL.
- Lot
- Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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