Upsher Smith Recalls Divalproex Sodium Tablets Due to Labeling Error
Upsher Smith is recalling 11,316 bottles of Divalproex Sodium Delayed-Release Tablets because some labels are missing the color-coded strength indicator.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.
Plain-English summary
Upsher Smith Laboratories, Inc. is recalling 11,316 bottles of Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity. The product is a prescription-only medication manufactured in Minneapolis, Minnesota, and distributed nationwide and in Puerto Rico. The specific lot number is 310162, with an expiration date of 09/14.
The recall was initiated due to a labeling error where some bottles were missing the color-coded strength on the primary display panel of the label. This omission could potentially cause confusion regarding the medication's strength, although the tablets themselves contain the correct 500 mg valproic acid activity.
Consumers who have this product should check their bottles for the missing color-coded strength indicator. If the label is affected, they should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
- Manufacturer
- Upsher Smith Laboratories, Inc.
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 11,316
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 (2)
- Lot #: 310162
- Exp 09/14
Distribution
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