Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Reported: February 2, 2022 Initiated: December 6, 2021 #D-0446-2022
Product Description
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Edge Pharma, LLC
- Units Affected
- 7788 syringes
- Distribution
- nationwide
- Location
- Colchester, VT
Frequently Asked Questions
What product was recalled? ▼
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01. Recalled by Edge Pharma, LLC. Units affected: 7788 syringes.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0446-2022.
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