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FDA (Drug enforcement)Recalled 2020-09-16closedclass ii

Perrigo Company PLC: Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distrib

Is my product affected?

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

  • Brand ALBUTEROL SULFATE

Check against the official notice below — it lists the full affected range.

What happened

Perrigo Company PLC is recalling approximately 7.8 million metered dose inhalers of Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) distributed nationwide in the United States. The inhalers, manufactured by Catalent Pharma Solutions in Morrisville, North Carolina, are being recalled due to a defective delivery system characterized by a sustained trend of complaints that the devices fail to dispense medication properly.

The recalled inhalers span multiple lot codes with expiration dates ranging from September 2020 through at least April 2022. The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Defective Delivery System: Sustained trend of failure to dispense complaints.

Details from the source

Reason for recall: Defective Delivery System: Sustained trend of failure to dispense complaints. Distribution: Nationwide in the U.S. Quantity: 7,775,813 metered dose inhalers Lot/code info: 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, 2

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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