Reported Sep 21, 2022 · Terminated

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10…

Pine Pharmaceuticals, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pine Pharmaceuticals, LLC · 355 Riverwalk Pkwy · Tonawanda, NY · 14150-5837

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection
803packaged in a) 10 mL prefilled syringe, , barcode 6919408031
9335 mL prefilled syringe, , barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.
Lot codes and dates
    • Lot #s: a) 58366
    • exp. date 09/26/2022
    • 60247
    • exp. date 12/04/2022
    • b) 54825
    • exp. date 08/10/2022
    • 57583
    • exp. date 08/22/2022
    • 59343
    • exp. date 10/30/2022
    • 60355
    • exp. date 10/11/2022
Amount recalled
a) 920 syringes; b) 3263 syringes

Where it was sold

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 19, 2022 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.