Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SPOT TRTMT 1 OZ SKU 2096507 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Drug: Adapalene
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
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