Recalls / Class II
Class IID-0826-2020
Product
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
- Affected lot / code info
- a) H19E83 Exp. 11/30/2020, E19A82 Exp. 05/31/2020; b) H19B20 Exp. 11/30/2020, G19D77 Exp. 05/31/2020, C19D84 Exp. 05/31/2020, D19A77 Exp. 05/31/2020, D19E40 Exp. 05/31/2020; c) I19C45 Exp. 11/30/2020, E19E42 Exp. 11/30/2020, G19B41 Exp. 11/30/2020, H19C77 Exp. 11/30/2020, E19A34 Exp. 05/31/2020; d) H19B61 Exp. 11/30/2020, H19C82 Exp. 11/30/2020, C19A18 Exp. 05/31/2020, C19B13 Exp. 05/31/2020, D19B77 Exp. 05/31/2020, E19B76 Exp. 05/31/2020; e) I19B41 Exp. 11/30/2020, D19D51 Exp. 05/31/2020, F19C33 Exp. 05/31/2020
Why it was recalled
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- N/A
- Distribution pattern
- AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
Timeline
- Recall initiated
- 2020-01-10
- FDA classified
- 2020-02-04
- Posted by FDA
- 2020-02-12
- Terminated
- 2021-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0826-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.