Home / Recalls / Altaire Pharmaceuticals, Inc. / D-0458-2020

D-0458-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

Recall Details

Product Type
Drugs
Report Date
November 27, 2019
Initiation Date
July 2, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90072 units

Product Description

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

18095 4/20

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  • D-0402-2020 Class II — CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distri (July 2, 2019)
  • D-0469-2020 Class II — TRP Blur Relief, 15 mL, NDC 17312-002-11 (July 2, 2019)
  • D-0379-2020 Class II — CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium (July 2, 2019)
  • D-0464-2020 Class II — Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15 (July 2, 2019)
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