The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0671-2017·Announced 2017-04-19

Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Failure

Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because high levels of a degradation product were detected.

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), 200 mg. The affected products are packaged in 60-count bottles (NDC 59746-317-60) and 100-count bottles (NDC 59746-317-01). The recall involves 19,682 bottles distributed nationwide in the USA.

The recall was initiated because the product failed impurities and degradation specifications. Specifically, high out-of-specification results were found for one of the known degradation products, m-chlorobenzoic acid. The affected lots are BU34002A and BU34003A (Expiration 11/16) and BU34001A (Expiration 10/16).

The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that the violation of the product's labeling or manufacturing requirements is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above.

The recalled product

Product
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), 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
19,682

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 (5)

  • Lot #s: a) BU34002A
  • BU34003A
  • Exp 11/16
  • b) BU34001A
  • Exp 10/16

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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