Agency classClass IIIOur severity:Low FDA (Drugs)·D-0207-2017·Announced 2016-12-28

Zydus Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

Zydus Pharmaceuticals is recalling Bupropion Hydrochloride Extended-Release Tablets because they failed to meet dissolution specifications at the 6-month time point.

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

Zydus Pharmaceuticals USA Inc. is recalling 16,356 bottles of Bupropion Hydrochloride Extended-Release Tablets (XL), 300 mg. The affected products are available in 30-count and 500-count bottles and were distributed nationwide. The recall was initiated because the tablets failed to meet dissolution specifications at the 6-month time point.

The specific lot numbers and expiration dates for the recalled 30-count bottles (NDC 68382-354-06) include MS1667 (exp 01/2018) and M601708 (exp 03/2018). For the 500-count bottles (NDC 68382-354-05), the affected lots include MS1667, MS1668, MS1669 (exp 01/2018); M601515, M601516 (exp 03/2018); M602920, M602921, M605399, M602937, M602938, M602939 (exp 04/2018); and M603988 (exp 06/2018).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. The FDA has classified this recall as Class III, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product: BUPROPION (BUPROPION)
Brand: BUPROPION
Manufacturer: Zydus Pharmaceuticals USA Inc
Category: Drug — Prescription Medication
Hazard: dissolution-failure
Affected units: 16,356

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 (18)

a) MS1667 exp 01/2018
M601708
exp 03/2018
b) MS1667
MS1668
MS1669
exp 01/2018
M601515
M601516
M602920
M602921
M605399
M602937
M602938
M602939
exp 04/2018
M603988
exp 06/2018

Distribution

Distributed nationwide across the United States.

Same brand · BUPROPION

Moderate
Zydus Recalls BUPROPION Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2016-11-30

Same manufacturer · Zydus Pharmaceuticals USA Inc

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