Promethazine HCl Topical Ointment recall: CGMP Deviations
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.…
Why was Promethazine HCl Topical Ointment recalled?
CGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
08-2021-02@9 12-15-2021, 08-2021-16@10 12-29-2021, 09-2021-08@6 01-21-2022, 09-2021-20@6 02-02-2022 & 10-2021-18@6 03-02-2022
- Product
- 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.…
- Recalling firm
- Edge Pharma, LLC
- Quantity
- 7788 syringes
- Distribution
- nationwide
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)