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.
Reported: December 18, 2019 Initiated: December 2, 2019 #D-0576-2020
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.
Reason for Recall
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 1,824 bottles
- Distribution
- Nationwide in the USA.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 1,824 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2019. Severity: Moderate. Recall number: D-0576-2020.
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