Recalls / Class II
Class IID-306-2013
Product
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.
- Affected lot / code info
- Lot # 68864; exp 04/13
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.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 1,258 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-18
- FDA classified
- 2013-04-30
- Posted by FDA
- 2013-05-08
- Terminated
- 2014-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-306-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.