Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Reported: February 27, 2019 Initiated: January 25, 2019 #D-0515-2019
Product Description
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Reason for Recall
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- a) 4896 tubes; b) 5064 tubes
- Distribution
- Nationwide, including Puerto Rico.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.. Recalled by Akorn Inc. Units affected: a) 4896 tubes; b) 5064 tubes.
Why was this product recalled? ▼
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0515-2019.
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