Jubilant Cadista Recalls Amantadine Hydrochloride Tablets Due to Foreign Object
Jubilant Cadista Pharmaceuticals is recalling 1,824 bottles of Amantadine Hydrochloride Tablets because a foreign object was found in a single tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling 1,824 bottles of Amantadine Hydrochloride Tablets, 100 mg, 100-count bottles. The product is prescription-only and was manufactured by Jubilant Generics Ltd. in India and marketed by Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD. The specific lot number is NT119005A with an expiration date of 07/2021.
The recall was initiated due to the presence of a foreign object in a single tablet. The agency has classified this as a Class II recall. The affected product was distributed nationwide in the USA.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,824
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 (2)
- Lot #: NT119005A
- Exp 07/2021
Distribution
Distributed nationwide across the United States.
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