Why it was recalled
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0826-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0826-2020, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 84820
- Address
- 727 N Ann Arbor Ave
- Code information
- 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
- Postal code
- 73127-5822
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0826-2020
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Termination date
- Mar 23, 2021
- Reason for recall
- CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
- Recall initiation date
- Jan 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2020