Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Reported: December 27, 2017 Initiated: August 3, 2017 #D-0120-2018
Product Description
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Reason for Recall
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 136376 bottles
- Distribution
- Nationwide
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 136376 bottles.
Why was this product recalled? ▼
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2017. Severity: Critical. Recall number: D-0120-2018.
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