Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Oxycodone HCl (Oxycodone Hydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specification; 9 month stability
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Affected NDC
0054-0390-41
Compare with the code on your package — it is the most precise check available.
Drug: Oxycodone
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 |
|---|---|---|---|---|
| oxycodone hydrochloride NDC 00054-0390 |
5 mg/5mL | Solution Oral |
Hikma Pharmceuticals USA Inc. | Rx · CII |
- Recalling firm
- West-Ward Columbus Inc
- NDC code
- 0054-0390-41
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1441-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxycodone recalls
See all
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class III · Low risk
Oxaydo (oxycodone HCl, USP)
Sub-potent Drug: Lower potency than labeled.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Other recalls by West-Ward Columbus Inc
All 2016 recalls
Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class III · Low risk
Methotrexate Tablets
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class III · Low risk
Ethacrynic Acid Tablets USP
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
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