Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Bexarotene Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
Affected NDC
0832-0285-00
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bexarotene NDC 00832-0285 |
75 mg/1 | Capsule Oral |
Upsher-Smith Laboratories, Inc. | Rx |
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1836-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Upsher Smith Laboratories, Inc.
All 2019 recalls
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class III · Low risk
Oxandrolone Tablets
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Class III · Low risk
Divalproex Sodium Delayed-Release Tablets
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Other dissolution failure recalls from 2019
All dissolution failure recalls
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class II · Moderate risk
Raloxifene Hydrochloride Tablets
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
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