Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA
Preferred Pharmaceuticals is recalling 99 bottles of Metformin HCl Extended Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported, the presence of NDMA above the ADI limit in a Class II drug recall aligns with the Severe criteria for significant potential harm.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling 99 bottles (9,990 tablets) of Metformin HCl Extended Release Tablets USP 500 mg. The product is a generic for Glucophage XR, manufactured by Time-Cap Labs, Inc. in Farmingdale, NY, under NDC #68788-6932-1.
The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. This constitutes a Current Good Manufacturing Practice (CGMP) deviation. The affected lots include E0620F with an expiration date of 12/31/2021, and G2020M with an expiration date of 04/30/2022.
The affected product was distributed to two physician's offices located in Florida. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- E0620F
- Exp.12/31/2021
- G2020M Exp.
- 04/30/2022
Distribution
Distributed in 1 state:
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