Recalls / Class I
Class ID-0120-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Lorazepam
- Generic name
- Lorazepam
- Active ingredient
- Lorazepam
- Route
- Oral
- NDC
- 65162-687
- FDA application
- ANDA091383
- Affected lot / code info
- Lot 06876016A, 06876017A, 06876018A, Exp 08/2018; 06876019A, 06876020A, 06876021A, 06876022A, Exp 09/2018; 06876023A, Exp 11/2018; 06876024A, 06876025A, Exp 12/2018; 06877001A, 06877002A, Exp 02/2019; 06877003A, Exp 03/2019.
Why it was recalled
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 136376 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-08-03
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2022-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0120-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.