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Class III: unlikely to cause harmTerminated

Pharmedium Services Buffered Lidocaine Recall

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class III
Reported by FDA
Mar 22, 2017
Recall ID
D-0603-2017
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled Buffered Lidocaine starting Jan 27, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0603-2017 on Mar 22, 2017. Reason: Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%. Status: Terminated.

Why it was recalled

Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

Product description

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466

Lot numbers, UPCs & expiration codes

Lot Numbers: 170110030M, 170110029M and 170070058M

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-0603-2017
Classification
Class III
Status
Terminated
Recall initiated
Jan 27, 2017
FDA report date
Mar 22, 2017
Quantity
3879 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0603-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
76661
Address
150 N Field Dr Ste 350
Code information
Lot Numbers: 170110030M, 170110029M and 170070058M
Postal code
60045-2506
Report date
Mar 22, 2017
Product type
Drugs
Recall number
D-0603-2017
Classification
Class III
Recalling firm
Pharmedium Services, LLC
Product quantity
3879 syringes
Termination date
Mar 16, 2017
Reason for recall
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Voluntary / mandated
Voluntary: Firm initiated
Product description
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
Distribution pattern
Nationwide
Recall initiation date
Jan 27, 2017
Initial firm notification
Telephone
Center classification date
Mar 15, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0603-2017, published Mar 22, 2017. 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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