Why it was recalled
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: NT119005A, Exp 07/2021
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0576-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 2, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- 1,824 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0576-2020, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84396
- Address
- 207 Kiley Dr
- Code information
- Lot #: NT119005A, Exp 07/2021
- Postal code
- 21801-2249
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0576-2020
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 1,824 bottles
- Termination date
- Oct 14, 2021
- Reason for recall
- Presence of Foreign Substance: Presence of a foreign object in a single tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2019