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Class II: temporary or reversible health riskTerminated

Edge Pharma Promethazine HCl Topical Ointment Recall

Promethazine HCl Topical Ointment, 2

Edge Pharma, LLC · Colchester, VT

Risk level
Class II
Reported by FDA
Feb 2, 2022
Recall ID
D-0446-2022
Check your lot numberHow we source this data

Summary

Edge Pharma recalled Promethazine HCl Topical Ointment starting Dec 6, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0446-2022 on Feb 2, 2022. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0446-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 6, 2021
FDA report date
Feb 2, 2022
Quantity
7788 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Edge Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-0446-2022, exactly as published.

Show all FDA fields
City
Colchester
State
VT
Status
Terminated
Country
United States
Event ID
89172
Address
856 Hercules Dr
Code information
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
Postal code
05446-8014
Report date
Feb 2, 2022
Product type
Drugs
Recall number
D-0446-2022
Classification
Class II
Recalling firm
Edge Pharma, LLC
Product quantity
7788 syringes
Termination date
Jun 7, 2023
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
nationwide
Recall initiation date
Dec 6, 2021
Initial firm notification
Press Release
Center classification date
Jan 24, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0446-2022, published Feb 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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