The Recall Desk
ModerateFDA (Drugs)·D-296-2013·Announced 2013-05-08

Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Manufacturing Deviations

Jubilant Cadista Pharmaceuticals is recalling specific lots of Pantoprazole Sodium Delayed Release Tablets because they were not manufactured in accordance with Good Manufacturing Practices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to cGMP deviations, which typically indicates a remote possibility of temporary or medically reversible health consequences, fitting the Moderate severity criteria for manufacturing issues without reported specific injuries.

Plain-English summary

Jubilant Cadista Pharmaceuticals Inc. is recalling 12,770 bottles of Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count. The affected products are identified by Lot PA22028 and Lot PA22029, both with an expiration date of 5/2014. The NDC number for the product is 59746-284-90.

The recall was initiated because the oral products were not manufactured in accordance with Good Manufacturing Practices (cGMP). The agency has classified this recall as Class II.

The affected products were distributed nationwide. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If you have the affected product, you should stop using it and contact your healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Manufacturer
Jubilant Cadista Pharmaceuticals Inc.
Category
Drug — Oral Solid Dosage
Hazard
Affected units
12,770

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 (1)

  • Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Jubilant Cadista Pharmaceuticals Inc.

See all →

Same hazard · cGMP deviation

See all →