Salisbury, MD, United States
Jubilant Cadista Pharmaceuticals, Inc. recalls
20 recalls recorded since 2018, most recently on 27 December 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls20
Ongoing (FDA)0
Terminated or completed20
Class I (FDA)2
Terminated Class III Drugs
- Recall started
- 27 December 2022
- Terminated
- 5 December 2023
- Reason
- Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0096-2023
- Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Terminated Class II Drugs
- Recall started
- 18 July 2022
- Terminated
- 22 November 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1294-2022, D-1293-2022
- Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
- Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Terminated Class III Drugs
- Recall started
- 1 April 2022
- Terminated
- 3 April 2023
- Reason
- Subpotent
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0752-2022
- Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
Terminated Class I Drugs
- Recall started
- 8 March 2022
- Terminated
- 15 November 2022
- Reason
- Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
- Distribution
- Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0767-2022
- Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
Terminated Class III Drugs
- Recall started
- 20 August 2021
- Terminated
- 5 April 2022
- Reason
- Subpotent
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0784-2021
- Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Terminated Class II Drugs
- Recall started
- 1 April 2021
- Terminated
- 28 April 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0333-2021
- Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
Terminated Class III Drugs
- Recall started
- 19 February 2021
- Terminated
- 15 November 2022
- Reason
- Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
- Distribution
- USA nationwide, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0298-2021
- Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
Terminated Class II Drugs
- Recall started
- 6 November 2020
- Terminated
- 23 March 2022
- Reason
- Failed Tablet/Capsule Specification
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0104-2021
- clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
Terminated Class III Drugs
- Recall started
- 26 October 2020
- Terminated
- 11 August 2021
- Reason
- Subpotent
- Distribution
- Product was distributed nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0066-2021
- Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury,
Terminated Class III Drugs
- Recall started
- 26 May 2020
- Terminated
- 15 November 2022
- Reason
- Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
- Distribution
- TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1281-2020
- Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 5974
Terminated Class II Drugs
- Recall started
- 11 March 2020
- Terminated
- 10 June 2020
- Reason
- CGMP Deviations: Presence of dark brown discoloration on edges of tablets
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1058-2020
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Terminated Class II Drugs
- Recall started
- 2 December 2019
- Terminated
- 14 October 2021
- Reason
- Presence of Foreign Substance: Presence of a foreign object in a single tablet.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0576-2020
- 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
Terminated Class II Drugs
- Recall started
- 4 September 2019
- Terminated
- 12 February 2020
- Reason
- CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
- Distribution
- Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0145-2020
- Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbur
Terminated Class I Drugs
- Recall started
- 9 July 2019
- Terminated
- 7 May 2021
- Reason
- Failed dissolution specifications : failed results at the 3-month stability time point.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1837-2019
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L.,
Terminated Class II Drugs
- Recall started
- 29 March 2019
- Terminated
- 20 September 2019
- Reason
- Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1074-2019
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 218
Terminated Class III Drugs
- Recall started
- 28 February 2019
- Terminated
- 5 March 2020
- Reason
- Failed Dissolution Specifications; 9-monthstability timepoint
- Distribution
- Product was distributed to one customer who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0519-2019
- BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubi
Terminated Class II Drugs
- Recall started
- 2 October 2018
- Terminated
- 24 February 2020
- Reason
- Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
- Distribution
- Product was distributed Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0011-2019
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 218
Terminated Class III Drugs
- Recall started
- 27 August 2018
- Terminated
- 8 October 2019
- Reason
- Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1205-2018
- MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Terminated Class III Drugs
- Recall started
- 14 August 2018
- Terminated
- 8 January 2020
- Reason
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Distribution
- Product was distributed throughout the United States to wholesalers and retailers.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1106-2018, D-1103-2018, D-1104-2018, D-1105-2018
- Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
- Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
- Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
- Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
Terminated Class III Drugs
- Recall started
- 25 May 2018
- Terminated
- 8 January 2020
- Reason
- Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- Distribution
- IN, MI, MS, NC, NJ, NY and OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0876-2018
- Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.