July 2022 FDA Recall Drug by Pine Pharmaceuticals, Llc
D-1514-2022 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Pine Pharmaceuticals, Llc on July 27, 2022 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed to direct accounts in AL, CA, NC and NY and the recall is currently terminated.

Recall Number: D-1514-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
07-27-2022
Reported
09-21-2022
Quantity
a) 920 syringes; b) 3263 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90854
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pine Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to direct accounts in AL, CA, NC and NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2022
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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