The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0669-2017·Announced 2017-04-19

Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Issues

Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Bupropion Hydrochloride Extended-release Tablets, USP (SR), 100 mg. The affected products are packaged in 60-count bottles (NDC 59746-315-60) and 100-count bottles (NDC 59746-315-01). The recall involves 20,882 bottles distributed nationwide in the USA.

The recall was initiated because of failed impurities and degradation specifications. Specifically, the products tested with high out-of-specification results for one of the known degradation products, m-chlorobenzoic acid. The affected lot numbers are BU15001B and BU15003D (expiration 12/16) for the 60-count bottles, and BU15002A (expiration 12/16) for the 100-count bottles.

The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers and discontinue use if found.

The recalled product

Product
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista…
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
20,882

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 (4)

  • Lot #s: a) BU15001B
  • BU15003D
  • Exp 12/16
  • b) BU15002A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Jubilant Cadista Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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