Teriparatide Injectable Syringes Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Teriparatide injectable syringes nationwide due to lack of assurance of sterility. Patients using affected batches should contact their healthcare provider immediately.
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: This is an FDA Class II recall of a compounded injectable product with lack of assurance of sterility, representing a risk-of-harm product. No illnesses or injuries have been reported in the source text, meeting the criteria for High severity.
Plain-English summary
Tailor Made Compounding is recalling Teriparatide 226 mcg/ml injectable syringes due to lack of assurance of sterility in the manufacturing process. The product is supplied in pre-filled syringes containing 0.25 mL each, packaged in groups of 12 syringes. Two batches are affected: batch 01132208A1 (expiration date 4/13/2022) and batch 02252205A1 (expiration date 5/26/2022).
The recall affects the entire product distribution, which was nationwide throughout the United States and Puerto Rico. Patients who have received or may receive Teriparatide from the affected batches are potentially at risk.
Patients who have been prescribed or received Teriparatide from the affected batches should contact their healthcare provider immediately. Do not use any remaining product from these batches. Return the recalled syringes to the pharmacy or healthcare facility where they were obtained.
The recalled product
- Product
- Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- contamination
- injection-safety
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 (4)
- Batch#: 01132208A1
- Exp 4/13/2022
- 02252205A1
- Exp 5/26/2022.
Distribution
Distributed nationwide across the United States.
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