Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Raloxifene Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
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
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
Affected NDCs
60687-0266-11
60687-0266-21
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 |
|---|---|---|---|---|
| Raloxifene Hydrochloride Raloxifene NDC 60687-0266 |
HYDROCHLORIDE 60 mg/1 | Tablet Oral |
American Health Packaging | Rx |
- Recalling firm
- American Health Packaging
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0854-2020 · 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 American Health Packaging
All 2019 recalls
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
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
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
Class III · Low risk
minolira (minocycline hydrochloride)
Failed Dissolution Specifications:
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