Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
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.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021…
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
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