CLASS II Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v recalled
Pine Pharmaceuticals is recalling Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or, distributed in Alabama, California, North Carolina, New York. The recall was initiated on 27 Jul 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1514-2022
- FDA event ID
- 90854
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 27 Jul 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +50 days |
| 21 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.
Where it was distributed
Product was distributed to direct accounts in AL, CA, NC and NY
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
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
Where was it sold?
Product was distributed to direct accounts in AL, CA, NC and NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pine Pharmaceuticals
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|---|---|---|---|---|---|
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| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |