Isomeric Pharmacy Recalls Betamethasone Injectable Suspension Due to Particle Issues
Isomeric Pharmacy Solution is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension due to potential drug clumps and larger particle sizes.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard involves particulate matter in a sterile injectable, which is a significant quality issue but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/mL, 10 mL Multi-Dose vials. The recall was initiated because of a lack of processing controls that resulted in the potential for drug clumps in the vials and larger particle sizes in the sterile drug product.
The affected product is distributed nationwide and in Puerto Rico. The recall covers 2,331 vials with specific lot numbers and expiration dates ranging from August 2016 to November 2016. The product is prescription-only.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
- Manufacturer
- Isomeric Pharmacy Solution, LLC
- Affected units
- 2,331
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 (20)
- Lot# 03037
- Exp 8/17/16
- 03042
- 03043
- Exp 8/31/16
- 04043
- Exp 9/29/16
- 04047
- 04048
- Exp 10/1/16
- 04052
- 04053
- Exp10/2/16
- 05042
- Exp 10/29/16
- 05046
- Exp 11/2/16
- 05048
- 05049
- Exp 11/3/16
Distribution
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