Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Reported: November 25, 2020 Initiated: November 1, 2020 #D-0077-2021
Product Description
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Details
- Recalling Firm
- Preferred Pharmaceuticals, Inc.
- Units Affected
- 99 bottles (9990 Extended Release Tablets)
- Distribution
- Distributed to two physician's offices located in FL.
- Location
- Anaheim, CA
Frequently Asked Questions
What product was recalled? ▼
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 99 bottles (9990 Extended Release Tablets).
Why was this product recalled? ▼
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2020. Severity: Moderate. Recall number: D-0077-2021.
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