Recalls / Class III
Class IIID-580-2013
Product
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
- Brand name
- Lorazepam
- Generic name
- Lorazepam
- Active ingredient
- Lorazepam
- Route
- Oral
- NDCs
- 0904-6007, 0904-6008, 0904-6009
- FDA application
- ANDA078203
- Affected lot / code info
- L-04009 Exp.11/15
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging LLC
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13480 Lakefront Dr, N/A, Earth City, Missouri 63045-1516
Distribution
- Quantity
- 1,644 bottles
- Distribution pattern
- Distribution was made to IN.
Timeline
- Recall initiated
- 2013-03-27
- FDA classified
- 2013-06-06
- Posted by FDA
- 2013-06-12
- Terminated
- 2014-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-580-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.