Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
Reported: September 22, 2021 Initiated: August 13, 2021 #D-0802-2021
Product Description
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
Reason for Recall
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Distribution
- USA Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701. Recalled by Akorn, Inc.. Units affected: 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289.
Why was this product recalled? ▼
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 22, 2021. Severity: Moderate. Recall number: D-0802-2021.
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