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Class II: temporary or reversible health riskTerminated

Pharmedium Services lidocaine HCl 2% Recall

lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume…

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class II
Reported by FDA
Oct 19, 2016
Recall ID
D-0067-2017
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled lidocaine HCl 2% starting Jul 17, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0067-2017 on Oct 19, 2016. Reason: Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. Status: Terminated.

Why it was recalled

Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.

Product description

lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.

Lot numbers, UPCs & expiration codes

Lot Numbers: 15112074M, 15113030M, Exp between 07/15/15-10/12/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0067-2017
Classification
Class II
Status
Terminated
Recall initiated
Jul 17, 2015
FDA report date
Oct 19, 2016
Quantity
512 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0067-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
73925
Address
150 N Field Dr Ste 350
Code information
Lot Numbers: 15112074M, 15113030M, Exp between 07/15/15-10/12/15
Postal code
60045-2506
Report date
Oct 19, 2016
Product type
Drugs
Recall number
D-0067-2017
Classification
Class II
Recalling firm
Pharmedium Services, LLC
Product quantity
512 syringes
Termination date
Jun 23, 2017
Reason for recall
Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
Voluntary / mandated
Voluntary: Firm initiated
Product description
lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.
Distribution pattern
Nationwide
Recall initiation date
Jul 17, 2015
Initial firm notification
E-Mail
Center classification date
Oct 12, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0067-2017, published Oct 19, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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