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Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured...

FDA Drug Recall #D-1594-2020 — Class II — September 16, 2020

Recall Summary

Recall Number D-1594-2020
Classification Class II — Moderate risk
Date Initiated September 16, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Perrigo Company PLC
Location Allegan, MI
Product Type Drugs
Quantity 7,775,813 metered dose inhalers

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide in the U.S.

Lot / Code Information

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

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Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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