Amneal Recalls Lorazepam Oral Concentrate Due to Defective Dropper Markings
Amneal Pharmaceuticals is recalling Lorazepam Oral Concentrate because dropper measurement markings may be reversed, shifted, or missing, which could lead to dosing errors.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling 136,376 bottles of Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL. The recall is due to a defective delivery system where the dropper measurement markings may be reversed, shifted, or missing.
The affected product is a prescription-only medication distributed nationwide. Specific lots include 06876016A through 06877003A, with expiration dates ranging from August 2018 to March 2019. The product is manufactured by Amneal Pharmaceuticals in Branchburg, NJ, and distributed by Amneal Pharmaceuticals in Glasgow, KY.
Consumers and healthcare providers should check their inventory for the affected lot numbers and stop using the product if the dropper markings are defective. They should contact their pharmacist or healthcare provider for guidance on alternative dosing methods or replacement medication.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 136,376
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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.
Distribution
Distributed nationwide across the United States.
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