Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Tramadol Hydrochloride Tablets USP CIV
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
What was recalled
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0093-0058-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0851-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Chloride recalls
See all
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules
Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
Naropin
Reason Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Cool Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow
Reason Lack of Assurance of Sterility
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