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
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, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
- Recalling firm
- Golden State Medical Supply Inc.
- NDC code
- 60429-588-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0856-2020
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.
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Class II · Moderate risk Ongoing
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Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
Naropin
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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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