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.
Reported: February 17, 2016 Initiated: March 2, 2015 #D-0661-2016
Product Description
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.
Reason for Recall
Defective Container: Confirmed customer complaints of leaking bottles.
Details
- Recalling Firm
- Safecor Health, LLC
- Units Affected
- 3,532 amber bottles
- Distribution
- NJ
- Location
- Woburn, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Safecor Health, LLC. Units affected: 3,532 amber bottles.
Why was this product recalled? ▼
Defective Container: Confirmed customer complaints of leaking bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 17, 2016. Severity: Moderate. Recall number: D-0661-2016.
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