The Recall Desk
SevereFDA (Drugs)·D-0724-2022·Announced 2022-03-30

Sincalide Injection Recalled for Potency and Reconstitution Issues

Olympia Compounding Pharmacy is recalling Sincalide lyophilized powder for injection due to concerns about super potency and failed reconstitution time. The product is distributed nationwide, including Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. 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. The hazards of super potency and failed reconstitution in an injectable pharmaceutical could result in improper drug delivery, dosing errors, or patient harm, meeting the threshold for Severe classification under the rubric.

Plain-English summary

Olympia Compounding Pharmacy, located in Orlando, Florida, is recalling Sincalide lyophilized powder for reconstitution (5 mcg per multi-dose vial, NDC 73198-0082-00, Lot D24001, expiration 4/1/22). The recall affects 836 vials distributed nationwide in the USA, including Puerto Rico.

The recall was initiated due to concerns regarding super potency and failed reconstitution time of the product. The compounded medication is supplied as a lyophilized powder requiring reconstitution with sterile water for injection prior to use.

Sincalide is a prescription injectable medication used in diagnostic imaging procedures. Patients who have received this product or healthcare providers who have administered it should consult with their physician regarding potential effects from use of this recalled lot.

The FDA classified this as a Class II recall. Consumers and healthcare providers with questions should contact Olympia Compounding Pharmacy or consult the FDA for additional guidance.

The recalled product

Product
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compou
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Injectable / Compounded Pharmaceutical
Hazard
  • super-potency
  • reconstitution-failure
  • improper-dosing

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 (1)

  • Lot: D24001 Exp. 4/1/22

Distribution

Distributed nationwide across the United States.

Related recalls

Same category