More Than 7 Million Defective Inhalers Recalled

Perrigo Company is recalling more than 7 million albuterol inhalers following customer complaints of a defective delivery system. The recall was included in the September 30, 2020, US Food and Drug Administration (FDA) Enforcement Report.  

The recall affects albuterol sulfate inhalation aerosol, 90 mcg per actuation, 200 metered inhalations (NDC 45802-088-01), from the following lots:

• 18MC-052, 18MC-055, 18MC-056, 18MC-057, 18MC-058, and 18MC-060 (Exp. 9/20);
• 18MC-061, 18MC-062, 18MC-064, 18MC-065, 18MC-066, 18MC-068, 18MC-069, 18MC-070, 18MC-071, 18MC-072, 18MC-073, and 18MC-074 (Exp. 10/20);
• 18MC-075, 18MC-076, 18MC-077, 18MC-078, 18MC-079, 18MC-080, 18MC-081, 18MC-082, 18MC-083, 18MC-084, and 18MC-085 (Exp. 11/20);
• 18MC-095, 18MC-096, 18MC-097, 18MC-098, and 18MC-099 (Exp. 12/20);
• 19MC-001, 19MC-002, 19MC-003, and 19MC-004 (Exp. 1/21);
• 19MC-005, 19MC-006, 19MC-007, 19MC-008, 19MC-009, 19MC-010, 19MC-011, 19MC-012, 19MC-013, 19MC-014, and 19MC-015 (Exp. 2/21);
• 19MC-020, 19MC-041, 19MC-042, 19MC-043, 19MC-044, and 19MC-045 (Exp. 4/21);
• 19MC-046, 19MC-047, 19MC-048, 19MC-049, 19MC-050, 19MC-051, and 19MC-052 (Exp. 5/21);
• 19MC-053, 19MC-054, 19MC-055, 19MC-056, 19MC-057, 19MC-059, and 19MC-060 (Exp. 6/21);
• 19MC-061, 19MC-062, 19MC-063, 19MC-064, 19MC-065, 19MC-066, 19MC-067, 19MC-068, 19MC-069, 19MC-070, 19MC-083, 19MC-084, and 19MC-085 (Exp. 7/21);
• 19MC-087, 19MC-088, 19MC-090, 19MC-091, 19MC-092, 19MC-093, 19MC-094, 19MC-095, 19MC-096, 19MC-097, 19MC-098, and 19MC-099 (Exp. 8/21);
• 19MC-101, 19MC-102, 19MC-103, 19MC-104, 19MC-107, 19MC-108, 19MC-109, 19MC-110, 19MC-112, and 19MC-113 (Exp. 9/21);
• 20MC-014, 20MC-015, 20MC-016, 20MC-017, 20MC-020, 20MC-021, and 20MC-072 (Exp. 3/22);
• 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, and 20MC-044 (Exp. 4/22);
• 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, and 20MC-068 (Exp. 5/22); and
• 20MC-069, 20MC-070, 20MC-078, 20MC-079, 20MC-080, 20MC-081, 20MC-083, and 20MC-084 (Exp. 6/22). 

The recalled inhalers were manufactured by Catalent Pharma Solutions and distributed by Perrigo throughout the United States. 

Perrigo voluntarily initiated the recall September 16, 2020. On September 23, 2020, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm exists. 

Albuterol is a prescription bronchodilator used to treat wheezing and shortness of breath caused by asthma and other breathing problems.

—Jolynn Tumolo