Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Petroleum jelly
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
- Recalling firm
- OraLabs, Incorporated
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0624-2020 · FDA notice
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other cross-contamination recalls from 2019
All cross-contamination recalls
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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