HTO Nevada Inc. Issues Nationwide Recall of VASOCAINE Spray Due to Stability Concerns
HTO Nevada Inc. dba Kirkman is voluntarily recalling 27,380 bottles of VASOCAINE Spray because stability data does not support the listed expiration dates.
What Happened
HTO Nevada Inc. dba Kirkman has initiated a voluntary recall of FIVE-STAR VASOCAINE Spray. The recall was prompted by findings that stability data for the product does not support the expiration dates currently listed on the packaging. The FDA has classified this as a Class II recall.
Which Products Are Affected
The recall affects 27,380 bottles of FIVE-STAR, VASOCAINE Spray (Lidocaine HCl 4%, Racepinephrine HCl 0.01%) in 4oz bottles. The product is distributed by Dermal Source, Portland, OR, under NDC 80069-016.
The following lot numbers and expiration dates are included in the recall:
- Lot 839CP-0016 (Exp. 03/31/2026)
- Lot 839CP-0017 (Exp. 06/30/2026)
- Lot 839CP-0018 (Exp. 08/31/2026)
- Lot 839CP-0019 (Exp. 10/31/2026)
- Lot 839CP-0020 (Exp. 03/31/2027)
- Lot 839CP-0021 (Exp. 07/31/2027)
- Lot 839CP-0022 (Exp. 11/30/2027)
- Lot 839CP-0023 (Exp. 02/29/2028)
- Lot 839CP-0024 (Exp. 07/31/2028)
What You Should Do
Consumers and healthcare providers should check their inventory for the affected lot numbers listed above. If you possess a bottle from a recalled lot, you should discontinue its use. For information regarding returns or further instructions, contact the recalling firm, HTO Nevada Inc. dba Kirkman, located in Lake Oswego, OR.
Why This Matters
This recall is necessary because the product’s shelf life cannot be guaranteed by current stability data. Using a drug beyond its actual stable period may result in decreased potency or unexpected changes in the product’s chemical composition.
Source
Information provided by the FDA (Recall Number: D-0385-2026).
Source: FDA Official Notice