Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA
Preferred Pharmaceuticals is recalling 144 bottles of Metformin HCl Extended Release Tablets, 500 mg, 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the detection of a carcinogenic impurity (NDMA) exceeding safety limits.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling 144 bottles of Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100. The product was manufactured by Time-Cap, Labs Inc. in Farmingdale, NY, and distributed by Preferred Pharmaceuticals in Anaheim, CA. The specific NDC is 68788-6932-01.
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 codes J0119M, K1419L, K2719J, and A0220H, all with an expiration date of 12/2020.
The product was distributed to two medical clinics located in Florida. Consumers and healthcare providers should stop using the affected 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, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 144
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 (5)
- J0119M
- K1419L
- K2719J
- A0220H
- Exp. Date 12/2020
Distribution
Distributed in 1 state:
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