Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Doxycycline
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
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, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Affected NDC
66993-0815-30
Compare with the code on your package — it is the most precise check available.
Drug: Doxycycline Category: Antibiotic
- Recalling firm
- Galderma Laboratories, L.P.
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1031-2016 · 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 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 Galderma Laboratories, L.P.
All 2016 recalls
Class III · Low risk
Capex Shampoo
Subpotent; fluocinolone acetonide.
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