The Recall Desk
SevereFDA (Drugs)·D-0940-2017·Announced 2017-07-12

Alvogen Recalls Clindamycin Injection Vials Due to Sterility Concerns

Alvogen, Inc. is recalling 72,575 vials of Clindamycin Injection USP due to a lack of assurance of sterility. The affected lots were distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the 'lack of assurance of sterility' for an injectable drug represents a significant risk of serious harm (sepsis/infection), aligning with the Severe criteria for high-risk drug defects.

Plain-English summary

Alvogen, Inc. is recalling 72,575 4 mL single-dose vials of Clindamycin Injection USP (600 mg/4 mL, 150 mg/mL). The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is identified by NDC 47781-463-69 and includes lots 68-104-EV (Exp 07/31/18), 73-155-EV (Exp 12/31/18), and 73-156-EV (Exp 12/31/18). These vials were distributed nationwide.

Healthcare providers and patients should stop using the affected lots and contact Alvogen, Inc. for further instructions or a replacement. This recall is classified as Class II by the FDA.

The recalled product

Product
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
Manufacturer
Alvogen, Inc
Category
Drug — Injectable
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: 68-104-EV
  • Exp 07/31/18
  • 73-155-EV
  • Exp. 12/31/18
  • 73-156-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 →

Related recalls

Same manufacturer · Alvogen, Inc

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Same hazard · sterility failure

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