Class II · Moderate risk Ongoing
Diovan
Reason Failed Dissolution Specifications
Amoxicillin and Clavulanate Potassium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
What was recalled
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 65862-503-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0852-2020
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 East recalls
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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.
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules
Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
Rising
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Class I · High risk Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
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