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
Reported: May 26, 2021 Initiated: April 28, 2021 #D-0385-2021
Product Description
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
Reason for Recall
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Details
- Recalling Firm
- Preferred Pharmaceuticals, Inc.
- Units Affected
- 147 bottles (14,700 extended release tablets)
- Distribution
- Distributed to two physician consignees located in FL.
- Location
- Anaheim, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 147 bottles (14,700 extended release tablets).
Why was this product recalled? ▼
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 26, 2021. Severity: Moderate. Recall number: D-0385-2021.
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