The Recall Desk
HighFDA (Drugs)·D-0742-2023·Announced 2023-05-31

FDA recalls epinephrine injection for lack of sterility assurance

Central Admixture Pharmacy Services recalled 8171 bags of epinephrine injection nationwide due to FDA concerns about sterility. The recalled prescription-only product was distributed across multiple lot numbers with expiration dates in 2023.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of injectable medication. While sterility assurance failures in injectables pose significant risk of harm, no illnesses or injuries have been reported. Per the severity rubric, theoretical hazards in high-risk products without confirmed actual harm score 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 8171 bags of epinephrine added to 0.9% sodium chloride injection (4 mg/250 mL, 16 mcg/mL) due to lack of assurance of sterility. An FDA inspection raised questions about whether these injectable products met sterility requirements.

The recalled product was distributed nationwide in the USA across multiple lot numbers with expiration dates from April through July 2023. Because this is a prescription-only injectable medication, it is used in healthcare settings.

Healthcare facilities that received this product should verify whether any recalled lots are in their inventory using the lot numbers and expiration dates provided in the recall notice. Patients who received treatment involving this medication should consult their healthcare provider if they have concerns.

The recalled product

Product
EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8093-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Pharmaceutical
Hazard
  • sterility-failure
  • contamination-risk

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 (20)

  • Lot # 37-882988
  • Exp 04/28/2023
  • 37-883194
  • 37-883208
  • Exp 04/30/2023
  • 37-884746
  • Exp 05/05/2023
  • 37-885215
  • Exp 05/08/2023
  • 37-885927
  • Exp 05/10/2023
  • 37-887044
  • 37-887051
  • Exp 05/15/2023
  • 37-887667
  • Exp 05/17/2023
  • 37-888297
  • 37-888298
  • Exp 05/21/2023
  • 37-890886

Distribution

Distributed nationwide across the United States.

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