Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Doxycycline Hyclate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Wrong Bar Code
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel)
Affected NDCs
0463-6000-50
24658-0312-05
Compare with the code on your package — it is the most precise check available.
Drug: Doxycycline Category: Antibiotic
- Recalling firm
- C. O. Truxton
- NDC code
- 0463-6000-50
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0164-2016 · 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 Doxycycline recalls
See all
Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Doxycycline Hyclate Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by C. O. Truxton
All 2015 recalls
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
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