Why it was recalled
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Product description
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Lot numbers, UPCs & expiration codes
Lot: A17F55 Exp. 06/30/2018
Where it was sold
Nationwide
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-1057-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 28, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 100 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1057-2017, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 77847
- Address
- 727 N Ann Arbor Ave
- Code information
- Lot: A17F55 Exp. 06/30/2018
- Postal code
- 73127-5822
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1057-2017
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 100 bottles
- Termination date
- Dec 6, 2017
- Reason for recall
- Failed Tablet/Capsule Specification: out of specification for tablet weight.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 28, 2017
- Initial firm notification
- Center classification date
- Aug 3, 2017