November 2019 FDA Recall Exparel by Pacira Pharmaceuticals, Inc.
D-0621-2020 - Sub Potent Drug
This Class II drug recall was voluntarily initiated by Pacira Pharmaceuticals, Inc. on November 21, 2019 for the product Exparel. The FDA reported the reason for recall as sub potent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0621-2020
Sub Potent Drug: Out of Specification (OOS)
11-21-2019
12-11-2019
910 20 mL vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pacira Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
06-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,
Batch or Lot Expiration Information
Lot# Pacira
Lot# : 19-5002, Patheon manufacturer
Lot# : 098214; Exp. Date: Dec 2019
