Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Hydroxychloroquine Sulfate Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
Affected NDC
0781-1407-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Sandoz Incorporated
- NDC code
- 0781-1407-01
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-66373-001 · 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 recalls by Sandoz Incorporated
All 2013 recalls
Class III · Low risk
Amitriptyline HCl Tablets
Cross Contamination With Other Product: Imipramine
Class II · Moderate risk
Nadolol Tablets
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Other failed specification recalls from 2013
All failed specification recalls
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Class II · Moderate risk
Niacin Extended Release Tablets
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Class II · Moderate risk
Daunorubicin Hydrochloride Injection
Presence of Precipitate; precipitation of drug product
Class II · Moderate risk
Oxygen
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
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