Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Lidocaine USP for prescription compounding
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Affected NDCs
58597-8019-04
58597-8019-06
58597-8019-07
58597-8019-08
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8019-4
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0507-2018 · 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 Lidocaine recalls
See all
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Hair was found in products
Class III · Low risk
Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Other recalls by American Pharmaceutical Ingredients LLC
All 2018 recalls
Class II · Moderate risk
Sermorelin Acetate
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Oxytocin USP
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Fluticasone propionate USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Cyanocobalamin USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.