Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
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 Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
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