FDA Recall D-0925-2018

Sanofi-Aventis U.S. LLC · Bridgewater, NJ

Class II Ongoing 2870 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00

Lot / code: Lot #: 7F021B, Exp 6/30/20

Quantity: 3214 prefilled pens

Reason for recall

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Recall record

Recall number: D-0925-2018
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2018-07-05
Classified by FDA Center: 2018-07-16
FDA published: 2018-07-18
Recalling firm: Sanofi-Aventis U.S. LLC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): ADMELOG
Generic name(s): INSULIN LISPRO
Manufacturer(s): Sanofi-Aventis U.S. LLC
NDC(s): 0024-5924, 0024-5925, 0024-5926
Route(s): INTRAVENOUS, SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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