Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10
Summary
The FDA issued a Class II for Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or by Pine Pharmaceuticals, LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-1514-2022
Action Date
2022-09-21
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: 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
Quantity Affected: a) 920 syringes; b) 3263 syringes
Reason for Recall
Lack of Assurance of Sterility
Distribution
Product was distributed to direct accounts in AL, CA, NC and NY
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-27
Company
Tonawanda, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pine Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pine Pharmaceuticals, LLC have FDA actions?
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1514-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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