Recalls / Class II
Class IID-1333-2020
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 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127
- Brand name
- Metformin Hydrochloride Extended Release
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDC
- 72789-009
- FDA application
- ANDA090295
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 1969 bottles
- Distribution pattern
- United States.
Timeline
- Recall initiated
- 2020-06-05
- FDA classified
- 2020-06-20
- Posted by FDA
- 2020-07-01
- Terminated
- 2021-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1333-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.