FDA Recalls Compounded Injectable Solution Due to Sterility Failure
Central Admixture Pharmacy Services recalled 653 bags of compounded injectable solution nationwide following an FDA inspection that questioned the product's sterility. The solution is intended for sterile injection use.
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 sterile injectable medication after inspection called sterility into question. Sterile injectables are high-risk products, but per the rubric, score 3 applies where no illnesses or injuries have been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 653 bags of MSA 7.84% MSG 8.56% compounded solution supplied in 1000 mL bags with NDC 71285-8029-1. The product was distributed nationwide in the United States. Affected lot numbers include 37-882955 (exp. 04/29/2023), 37-884753, 37-884755 (exp. 05/06/2023), 37-887536, 37-887537 (exp. 05/17/2023), 37-888532 (exp. 05/23/2023), 37-892474 (exp. 06/07/2023), 37-896761 (exp. 06/23/2023), and 37-897261 (exp. 06/27/2023).
An FDA inspection called into question the sterility of these products intended for sterile injection use. The recall was initiated due to lack of assurance of sterility.
Healthcare providers and patients who may have received this product should be aware of this recall and contact their healthcare provider if they have any questions or concerns.
The recalled product
- Product
- MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 653
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 (16)
- Lot # 37-882955
- Exp 04/29/2023
- 37-884753
- 37-884755
- Exp 05/06/2023
- 37-887536
- 37-887537
- Exp 05/17/2023
- 37-888532
- Exp 05/23/2023
- 37-892474
- Exp 06/07/2023
- 37-896761
- Exp 06/23/2023
- 37-897261
- Exp 06/27/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 recalled by Central Admixture Pharmacy Services, 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.
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