The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1390-2014·Announced 2014-06-25

John W Hollis Inc Recalls Cyanocobalamin Injection Due to Sterility Concerns

John W Hollis Inc is recalling specific lots of Cyanocobalamin injection because the products lack assurance of sterility. The recall covers 2,650 mL 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the lack of sterility in injectables) are rated as Severe (4).

Plain-English summary

John W Hollis Inc is recalling 2,650 mL of Cyanocobalamin for intramuscular or subcutaneous use. The recall is due to a lack of assurance of sterility in the compounded aseptically filled injectable products. The affected product is a 30 mL vial containing 1000 mcg of Cyanocobalamin per mL, along with Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide.

The recall covers five specific lots: Lot # 940 (Best used by 08/01/14), Lot # 1090 (Best used by 08/29/14), Lot # 1533 (Best used by 05/24/14), Lot # 1838 (Best used by 07/15/14), and Lot # 2755 (Best used by 10/06/14). The products were distributed nationwide.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203…
Manufacturer
John W Hollis 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 (10)

  • Lot # 940
  • Best used by 08/01/14
  • Lot # 1090
  • Best used by 08/29/14
  • Lot # 1533
  • Best used by 05/24/14
  • Lot # 1838
  • Best used by 07/15/14
  • Lot# 2755
  • Best used by 10/06/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by John W Hollis 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 19 products in this recall →

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