Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Product description
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Lot numbers, UPCs & expiration codes
Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
Where it was sold
U.S. 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-0162-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 21, 2015
- FDA report date
- Nov 11, 2015
- Quantity
- 61,146 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0162-2016, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 72493
- Address
- 150 Vintage Dr NE
- Code information
- Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
- Postal code
- 35811-8216
- Report date
- Nov 11, 2015
- Product type
- Drugs
- Recall number
- D-0162-2016
- Classification
- Class III
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Product quantity
- 61,146 Bottles
- Termination date
- Oct 23, 2016
- Reason for recall
- Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Oct 21, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2015