Recalls / Class II
Class IID-0661-2016
Product
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
- Affected lot / code info
- Lot #846881; Exp 01/16
Why it was recalled
Defective Container: Confirmed customer complaints of leaking bottles.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 317 New Boston St, N/A, Woburn, Massachusetts 01801-6231
Distribution
- Quantity
- 3,532 amber bottles
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2015-03-02
- FDA classified
- 2016-02-11
- Posted by FDA
- 2016-02-17
- Terminated
- 2016-02-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0661-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.