Home / Recalls / Ecometics, Inc. / D-1101-2023

D-1101-2023 Class II

Recalled by Ecometics, Inc. — Norwalk, CT

Recall Details

Product Type
Drugs
Report Date
August 30, 2023
Initiation Date
August 9, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92,967 vials

Product Description

AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.

Reason for Recall

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 2E144A, 2E157A, exp: 11/2023; 2E270A, exp: 3/2024; 2E300A, exp: 4/2024

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  • D-0446-2023 Class II — Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 m (February 24, 2023)
  • D-0451-2023 Class II — Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral (February 24, 2023)
  • D-0452-2023 Class II — Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor (February 24, 2023)
  • D-0449-2023 Class II — Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plas (February 24, 2023)