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.
What this means for you
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
- 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.
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