The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0619-2018·Announced 2018-04-11

InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.

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 2/5 (Moderate).

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 III, which indicates a violation of labeling or the FD&C Act that is not likely to cause adverse health consequences. The failure of dissolution specifications is a quality control issue that may affect drug efficacy but does not present an immediate safety hazard like contamination or mislabeling of allergens.

Plain-English summary

InvaGen Pharmaceuticals, Inc. is recalling specific lots of Bupropion Hydrochloride (SR) Extended-Release Tablets, USP, 150 mg. The affected products are sold in 60-count and 100-count bottles under NDC 69097-878-03 and NDC 69097-878-07. The recall is being conducted because the tablets failed to meet dissolution specifications during stability testing.

The recall covers specific lot numbers with expiration dates ranging from May 2018 to September 2018. The products were distributed nationwide. The manufacturer is InvaGen Pharmaceuticals, Inc., a subsidiary of Cipla Ltd., and the products were manufactured for Cipla USA Inc.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
Brand
BUPROPION HYDROCHLORIDE (SR)
Manufacturer
InvaGen Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard

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)

  • a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018
  • Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018
  • Lot I1607847 and Lot I1607845 Exp Date 06/2018
  • Lot I1610639 Exp Date 09/2018

UPCs (3)

  • 0369097879037
  • 0369097878030
  • 0369097877033

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by InvaGen 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 2 products in this recall →

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