metFORMIN HCL ER 500 mg recall: Nitrosamine Impurity
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC…
Why was metFORMIN HCL ER 500 mg recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020; b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020; c) I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020; d) I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. 12/31/2020; e) XP9004 Exp. 12/31/2020
- Product
- metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC…
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Quantity
- 1969 bottles
- Distribution
- United States.
- Recall date
- July 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)