Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Reported: September 1, 2021 Initiated: August 13, 2021 #D-0766-2021
Product Description
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Reason for Recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Details
- Recalling Firm
- SigmaPharm Laboratories LLC
- Units Affected
- 1,993 bottles
- Distribution
- Disttibuted Nationwide in the USA.
- Location
- Bensalem, PA
Frequently Asked Questions
What product was recalled? ▼
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4. Recalled by SigmaPharm Laboratories LLC. Units affected: 1,993 bottles.
Why was this product recalled? ▼
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0766-2021.
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