September 2020 FDA Recall Albuterol Sulfate by Perrigo Company Plc
D-1594-2020 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Perrigo Company Plc on September 16, 2020 for the product Albuterol Sulfate. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1594-2020
Defective Delivery System: Sustained trend of failure to dispense complaints.
09-16-2020
09-30-2020
7,775,813 metered dose inhalers
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.
Perrigo Company PLC
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.
Nationwide in the U.S.
05-22-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01
Batch or Lot Expiration Information
Lot# 18MC-052, 18MC-055, 18MC-056, 18MC-057, 18MC-058, 18MC-060, EXP 09/2020; 18MC-061, 18MC-062, 18MC-064, 18MC-065, 18MC-066, 18MC-068, 18MC-069, 18MC-070, 18MC-071, 18MC-072, 18MC-073, 18MC-074 EXP 10/2020; 18MC-075, 18MC-076, 18MC-077, 18MC-078, 18MC-079, 18MC-080, 18MC-081, 18MC-082, 18MC-083, 18MC-084, 18MC-085 EXP 11/2020; 18MC-095, 18MC-096, 18MC-097, 18MC-098, 18MC-099 EXP 12/2020; 19MC-001, 19MC-002, 19MC-003, 19MC-004 EXP 1/2021; 19MC-005, 19MC-006, 19MC-007, 19MC-008, 19MC-009, 19MC-010, 19MC-011, 19MC-012, 19MC-013, 19MC-014, 19MC-015 EXP 2/2021; 19MC-020, 19MC-041, 19MC-042, 19MC-043, 19MC-044, 19MC-045 EXP 4/2021; 19MC-046, 19MC-047, 19MC-048, 19MC-049, 19MC-050, 19MC-051, 19MC-052 EXP 5/2021; 19MC-053, 19MC-054, 19MC-055, 19MC-056, 19MC-057, 19MC-059, 19MC-060 EXP 6/2021; 19MC-061, 19MC-062, 19MC-063, 19MC-064, 19MC-065, 19MC-066, 19MC-067, 19MC-068, 19MC-069, 19MC-070, 19MC-083, 19MC-084, 19MC-085 EXP 7/2021; 19MC-087, 19MC-088, 19MC-090, 19MC-091, 19MC-092, 19MC-093, 19MC-094, 19MC-095, 19MC-096, 19MC-097, 19MC-098, 19MC-099 EXP 8/2021; 19MC-101, 19MC-102, 19MC-103, 19MC-104, 19MC-107, 19MC-108, 19MC-109, 19MC-110, 19MC-112, 19MC-113 EXP 9/2021; 20MC-014, 20MC-015, 20MC-016, 20MC-017, 20MC-020, 20MC-021, 20MC-072 EXP 3/2022; 20MC-022, 20MC-023, 20MC-024, 20MC-029, 20MC-030, 20MC-032, 20MC-034, 20MC-035, 20MC-036, 20MC-037, 20MC-038, 20MC-039, 20MC-040, 20MC-041, 20MC-042, 20MC-043, 20MC-044 EXP 4/2022; 20MC-045, 20MC-046, 20MC-047, 20MC-048, 20MC-049, 20MC-050, 20MC-051, 20MC-052, 20MC-053, 20MC-054, 20MC-061, 20MC-062, 20MC-063, 20MC-064, 20MC-065, 20MC-066, 20MC-067, 20MC-068 EXP 5/2022; 20MC-069, 20MC-070, 20MC-078, 20MC-079, 20MC-080, 20MC-081, 20MC-083, 20MC-084 EXP 6/2022
