The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0126-2021·Announced 2020-12-16

Shilpa Medicare Recalls Docetaxel Injection Due to Manufacturing Deviations

Shilpa Medicare Limited is recalling 2,008 vials of Docetaxel Injection USP due to Current Good Manufacturing Practice (CGMP) deviations.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it represents a situation that might cause temporary or medically reversible adverse health consequences.

Plain-English summary

Shilpa Medicare Limited is voluntarily recalling 2,008 vials of Docetaxel Injection USP 160 mg/8mL (20 mg/mL). The product is distributed by Armas Pharmaceuticals, Inc., in Manalapan, New Jersey, and was distributed nationwide in the United States. The specific lot number is 7S10185A, with an expiration date of 10/31/2021.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected product. The recall was initiated on December 8, 2020, and was terminated on March 11, 2022.

The recalled product

Product
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
Manufacturer
Shilpa Medicare Limited
Category
Drug — Injection
Hazard
Affected units
2,008

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 (2)

  • Lot #: 7S10185A
  • Exp. 10/31/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Shilpa Medicare Limited 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 6 products in this recall →

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