Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Product description
Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
Lot numbers, UPCs & expiration codes
Lot # 68864; exp 04/13
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-306-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 18, 2013
- FDA report date
- May 8, 2013
- Quantity
- 1,258 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-306-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64753
- Address
- 465 Industrial Way W
- Code information
- Lot # 68864; exp 04/13
- Postal code
- 07724-2209
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-306-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 1,258 bottles
- Termination date
- Apr 30, 2014
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 30, 2013