Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
Reported: June 29, 2022 Initiated: June 9, 2022 #D-1152-2022
Product Description
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
Reason for Recall
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Details
- Recalling Firm
- Mayne Pharma Inc
- Units Affected
- 1440 cartons
- Distribution
- Nationwide in the US Market
- Location
- Greenville, NC
Frequently Asked Questions
What product was recalled? ▼
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834. Recalled by Mayne Pharma Inc. Units affected: 1440 cartons.
Why was this product recalled? ▼
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 29, 2022. Severity: Moderate. Recall number: D-1152-2022.
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