Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.
DMRC reference number
DMRC-38487919
Marketing Authorisation Holder
Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515)
Medicine Details
KidNaps (Melatonin) 1mg in 1ml Oral Solution
Licence: MS 32515
Active ingredient: melatonin
SNOMED code: N/A
GTIN: 5060191450331
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1743 | Mar 2026 | 200ml | 05/11/2024 |
| 1744 | Mar 2026 | 200ml | 12/11/2024 |
| 1787 | Jun 2026 | 200ml | 04/02/2025 |
| 1788 | Jun 2026 | 200ml | 21/02/2025 |
| 1852 | Dec 2026 | 200ml | 22/04/2025 |
| 1853 | Dec 2026 | 200ml | 27/06/2025 |
| 1955 | Jun 2027 | 200ml | 02/09/2025 |
| 1956 | Jun 2027 | 200ml | 05/11/2025 |
| 1992 | Sep 2027 | 200ml | 14/12/2025 |
| 1993 | Sep 2027 | 200ml | 05/02/2026 |
Background
Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515) and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution within expiry due to confirmed out of specification results from annual stability testing relating to product appearance and total impurities.
Advice for Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
Advice for Patients:
No action is required by patients, the recall is at the wholesaler and pharmacy level.
The recall is being undertaken out of an abundance of caution, patients using this medication may continue to do so. No adverse reactions have been reported from patients using this product. Patients or carers who have concerns about their medication should speak to their healthcare professional in the first instance.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information:
For medical information enquiries on this product, email centralmedicalinformation@veritonpharma.com or telephone +44 (0)1932 690325.
For stock control enquiries, email orders@veritonpharma.com or telephone +44 (0)1932 690325.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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