Why it was recalled
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Product description
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Lot numbers, UPCs & expiration codes
Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017
Where it was sold
Nationwide and Puerto Rico
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-0809-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 17, 2015
- FDA report date
- Apr 13, 2016
- Quantity
- 103,664 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bio-pharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0809-2016, exactly as published.
Show all FDA fields
- City
- Levittown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 72819
- Address
- 2091 Hartel Ave
- Code information
- Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017
- Postal code
- 19057-4506
- Report date
- Apr 13, 2016
- Product type
- Drugs
- Recall number
- D-0809-2016
- Classification
- Class III
- Recalling firm
- Bio-pharm, Inc.
- Product quantity
- 103,664 Bottles
- Termination date
- May 8, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 17, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2016