The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1514-2016·Announced 2016-09-28

Sandoz Recalls Phenylephrine Injection Due to Sterility Concerns

Sandoz Inc. is recalling specific lots of Phenylephrine HCI Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

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, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility compromise in an injectable medication.

Plain-English summary

Sandoz Inc. is recalling Phenylephrine HCI Injection, USP, 10mg/mL, in 5 mL and 10 mL vials. The recall affects specific lots distributed nationwide and in Puerto Rico.

The recall was initiated because a recent FDA inspection at the manufacturing firm raised concerns that the product's sterility may be compromised. This lack of assurance of sterility poses a potential risk to patients using the medication.

Healthcare providers and patients should stop using the affected lots immediately. The affected lots are 091914 (Exp 09/16) for 5 mL vials, and 080114, 090414, and 092614 (Exp 08/16 or 09/16) for 10 mL vials. Users should contact their healthcare provider for guidance on alternative treatments.

The recalled product

Product
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Manufacturer
Sandoz Inc
Category
Drug — Injectable Medication
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)

  • Lot #: a) 091914
  • Exp 09/16
  • b) 080114
  • Exp 08/16
  • 090414
  • 092614

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Sandoz 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 2 products in this recall →

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