The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0941-2017·Announced 2017-07-12

Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

Alvogen, Inc. is recalling specific lots of Clindamycin Injection USP due to a lack of assurance of sterility. The recall covers 71,825 vials distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death from infection.

Plain-English summary

Alvogen, Inc. is recalling 71,825 6 mL single-dose vials of Clindamycin Injection USP (900 mg/6 mL). The recall is being conducted because of a lack of assurance of sterility in the product. The affected product is manufactured for Alvogen, Inc., located in Pine Brook, NJ, and is available by prescription only.

The recall includes lots 68-105-EV (expiration 07/31/18), 68-106-EV (expiration 07/31/18), and 73-157-EV (expiration 12/31/18). The product was distributed nationwide. The NDC number for the recalled product is 47781-464-69.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If you have this product, do not use it and contact your healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
Manufacturer
Alvogen, Inc
Category
Drug — Injectable Antibiotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lots: 68-105-EV
  • Exp. 07/31/18
  • 68-106-EV
  • Exp. 07/31/18
  • and 73-157-EV
  • Exp. 12/31/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Alvogen, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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